30 results on '"Andrews KW"'
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2. MI1: IDENTIFYING FACTORS ASSOCIATED WITH HIGH AND LOW COST ASTHMATICS: OPPORTUNITIES FOR DISEASE MANAGEMENT USING AUTOMATIC INTERACTION DETECTION
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Boscarino, JA, primary, Zhao, Z, additional, Andrews, KW, additional, Sokol, MC, additional, Yao, J, additional, McGuigan, KA, additional, Gutierrez, B, additional, and Refowitz, R, additional
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- 2000
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3. Iodine in Foods and Dietary Supplements: A Collaborative Database Developed by NIH, FDA and USDA.
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Pehrsson PR, Roseland JM, Patterson KY, Phillips KM, Spungen JH, Andrews KW, Gusev PA, Gahche JJ, Haggans CJ, Merkel JM, and Ershow AG
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Data on the iodine content of foods and dietary supplements are needed to develop general population intake estimates and identify major contributors to intake. Samples of seafood, dairy products, eggs, baked products, salts, tap water, other foods and beverages, and dietary supplements were collected according to established sampling plans of the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Samples were assayed for iodine content using inductively coupled plasma mass spectrometry with rigorous quality control measures. The food data were released through a collaboration of USDA, FDA, and the Office of Dietary Supplements-National Institutes of Health (ODS-NIH) as the USDA, FDA, and ODS-NIH Database for the Iodine Content of Common Foods at www.ars.usda.gov/mafcl. Iodine data for dietary supplements are available in the ODS-USDA Dietary Supplement Ingredient Database and the ODS Dietary Supplement Label Database. Data from the iodine databases linked to national dietary survey data can provide needed information to monitor iodine status and develop dietary guidance for the general U.S. population and vulnerable subgroups. This iodine information is critical for dietary guidance development, especially for those at risk for iodine deficiency (i.e., women of reproductive age and young children)., Competing Interests: Conflicts of interest The authors, shown above, have no conflicts of interest.
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- 2022
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4. Do Multivitamin/Mineral Dietary Supplements for Young Children Fill Critical Nutrient Gaps?
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Dwyer JT, Saldanha LG, Bailen RA, Gahche JJ, Potischman N, Bailey RL, Jun S, Long Y, Connor E, Andrews KW, Pehrsson PR, and Gusev PA
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- Child, Preschool, Cross-Sectional Studies, Databases as Topic, Food Labeling, Humans, Infant, Nutrition Policy, Nutritional Status, Recommended Dietary Allowances, United States, Dietary Supplements, Micronutrients administration & dosage, Nutritional Requirements, Trace Elements administration & dosage, Vitamins administration & dosage
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Background: Nearly a third of young US children take multivitamin/mineral (MVM) dietary supplements, yet it is unclear how formulations compare with requirements., Objective: Describe the number and amounts of micronutrients contained in MVMs for young children and compare suggested amounts on product labels to micronutrient requirements., Design: Cross-sectional., Setting: All 288 MVMs on the market in the United States in the National Institutes of Health's Dietary Supplement Label Database in 2018 labeled for children 1 to <4 years old., Main Outcome Measures: Number of MVM products and amounts per day of micronutrients in each product suggested on labels compared with requirements represented by age-appropriate Daily Values (DV). Micronutrients of public health concern identified by the Dietary Guidelines for Americans (DGA) 2015-2020 (DGA 2015) and DGA 2020-2025 (DGA 2020) or those of concern for exceeding the upper tolerable intake levels., Statistical Analyses: Number of products and percent DV per day provided by each micronutrient in each product., Results: The 288 MVMs contained a mean of 10.1 ± 2.27 vitamins and 4.59 ± 2.27 minerals. The most common were, in rank order, vitamins C, A, D, E, B
6 , B12 ; zinc, biotin, pantothenic acid, iodine, and folic acid. For micronutrients denoted by the DGA 2015 and DGA 2020 of public health concern, 56% of the 281 products containing vitamin D, 4% of the 144 with calcium, and none of the 60 containing potassium provided at least half of the DV. The upper tolerable intake level was exceeded by 49% of 197 products with folic acid, 17% of 283 with vitamin A, and 14% of 264 with zinc. Most MVMs contained many of 16 other vitamins and minerals identified in national surveys as already abundant in children's diets., Conclusions: A reexamination of the amounts and types of micronutrients in MVMs might consider formulations that better fill critical gaps in intakes and avoid excess., (Copyright © 2022 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)- Published
- 2022
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5. Analytical Challenges and Metrological Approaches to Ensuring Dietary Supplement Quality: International Perspectives.
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Durazzo A, Sorkin BC, Lucarini M, Gusev PA, Kuszak AJ, Crawford C, Boyd C, Deuster PA, Saldanha LG, Gurley BJ, Pehrsson PR, Harnly JM, Turrini A, Andrews KW, Lindsey AT, Heinrich M, and Dwyer JT
- Abstract
The increased utilization of metrology resources and expanded application of its' approaches in the development of internationally agreed upon measurements can lay the basis for regulatory harmonization, support reproducible research, and advance scientific understanding, especially of dietary supplements and herbal medicines. Yet, metrology is often underappreciated and underutilized in dealing with the many challenges presented by these chemically complex preparations. This article discusses the utility of applying rigorous analytical techniques and adopting metrological principles more widely in studying dietary supplement products and ingredients, particularly medicinal plants and other botanicals. An assessment of current and emerging dietary supplement characterization methods is provided, including targeted and non-targeted techniques, as well as data analysis and evaluation approaches, with a focus on chemometrics, toxicity, dosage form performance, and data management. Quality assessment, statistical methods, and optimized methods for data management are also discussed. Case studies provide examples of applying metrological principles in thorough analytical characterization of supplement composition to clarify their health effects. A new frontier for metrology in dietary supplement science is described, including opportunities to improve methods for analysis and data management, development of relevant standards and good practices, and communication of these developments to researchers and analysts, as well as to regulatory and policy decision makers in the public and private sectors. The promotion of closer interactions between analytical, clinical, and pharmaceutical scientists who are involved in research and product development with metrologists who develop standards and methodological guidelines is critical to advance research on dietary supplement characterization and health effects., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Durazzo, Sorkin, Lucarini, Gusev, Kuszak, Crawford, Boyd, Deuster, Saldanha, Gurley, Pehrsson, Harnly, Turrini, Andrews, Lindsey, Heinrich and Dwyer.)
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- 2022
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6. Disintegration and Dissolution Testing of Green Tea Dietary Supplements: Application and Evaluation of United States Pharmacopeial Standards.
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Gusev PA, Andrews KW, Savarala S, Tey PT, Han F, Oh L, Pehrsson PR, Dwyer JT, Betz JM, Kuszak AJ, Costello R, and Saldanha LG
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- Capsules, Solubility, Tablets, United States, Dietary Supplements, Tea
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Approved performance quality tests are lacking in the United States Pharmacopeia (USP) for dietary supplements (DSs) containing green tea extracts. We evaluated the applicability of USP <2040 > general chapter protocols for disintegration and dissolution testing of botanicals to GT DSs. Of 28 single-ingredient GT DSs tested in 2 to 4 lots, 9 (32.1%) always passed the disintegration test, 8 (28.6%) always failed, and 11 (39.3%) showed inconsistent results. Of 34 multi-ingredient DSs tested in 2 lots, 21 (61.8%) passed and 8 (23.5%) failed in both lots, and 5 (14.7%) exhibited inconsistent performance. When stronger destructive forces were applied (disk added), all of the capsules that had failed initially, but not the tablets, passed. In dissolution testing, for the release of epigallocatechin-3-gallate (EGCG), only 6 of 20 single-ingredient DSs passed. Unexpectedly, with the addition of pepsin (prescribed by USP), only one additional DS passed. These results raise concerns that EGCG was not released properly from GT DS dosage forms. However, the general USP protocols may be inadequate for this botanical. More biorelevant destructive forces may be needed to break down capsules and tablets strengthened by the EGCG's interaction with shell material and to overcome the inhibition of digestive enzymes by EGCG., (Copyright © 2020 American Pharmacists Association®. All rights reserved.)
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- 2020
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7. The Chemical Forms of Iron in Commercial Prenatal Supplements Are Not Always the Same as Those Tested in Clinical Trials.
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Saldanha LG, Dwyer JT, Andrews KW, and Brown LL
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- Biological Availability, Clinical Trials as Topic, Female, Ferrous Compounds administration & dosage, Humans, Iron pharmacokinetics, Iron, Dietary administration & dosage, Iron, Dietary pharmacokinetics, Pregnancy, Prenatal Care, Prenatal Nutritional Physiological Phenomena, Safety, Dietary Supplements analysis, Iron chemistry
- Abstract
In the US, 70% of pregnant women use an iron-containing prenatal supplement product; however, only 2.6% of pregnant women have iron-deficiency anemia and 16.3% are iron deficient. Yet, published data on the amounts and chemical forms of iron used in formulating these products are not available, although they are known to affect bioavailability. This information is especially important in comparing commercially available products with those that were tested in clinical trials. Our examination of nonprescription and prescription iron-containing prenatal supplement products in NIH's Dietary Supplement Label Database (DSLD) and DailyMed found the labeled amount of elemental iron ranged between 9 and 60 mg/serving in 148 nonprescription supplements and between 4.5 and 106 mg/serving in 101 prescription supplements. Ferrous fumarate was the preferred chemical form used in these products. In contrast, ferrous sulfate was the preferred chemical form of iron reported in the clinical trials summarized in a 2015 Cochrane Systematic review assessing the effects of daily oral iron supplements for pregnant women. Ferrous sulfate was not found on any prenatal supplement product label in the DSLD or DailyMed. The chemical forms of products on the market and those tested in clinical trials are dissimilar, and we believe this may have clinical implications. The findings raise several questions. Do outcomes in clinical trials correlate with the benefits and risks that might adhere to iron supplements with different iron formulations? Should the differences in chemical forms, their bioavailability, and safety profiles, be considered in greater depth when evaluating the effect of the various formulations on maternal iron nutriture? Should new clinical trials for pregnant and lactating women in the US use a form of iron not found in prenatal supplements sold in the US or should a more common form be used?, (Published by Oxford University Press on behalf of the American Society for Nutrition 2019.)
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- 2019
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8. Dietary Supplement Ingredient Database (DSID) and the Application of Analytically Based Estimates of Ingredient Amount to Intake Calculations.
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Andrews KW, Gusev PA, McNeal M, Savarala S, Dang PTV, Oh L, Atkinson R, Pehrsson PR, Dwyer JT, Saldanha LG, Betz JM, Costello RB, and Douglass LW
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- Dietary Supplements standards, Food Labeling standards, Humans, Laboratories, Minerals administration & dosage, Minerals analysis, Minerals standards, Nutrition Surveys, Quality Control, United States, Vitamins administration & dosage, Vitamins analysis, Vitamins standards, Databases, Factual, Dietary Supplements analysis
- Abstract
Objective: We describe the purpose of the Dietary Supplement Ingredient Database (DSID), the statistical methodology underlying online calculators of analytically verified supplement content estimates, and the application and significance of DSID label adjustments in nutritional epidemiology., Background and History: During dietary supplement (DS) manufacturing, many ingredients are added at higher than declared label amounts, but overages are not standardized among manufacturers. As a result, researchers may underestimate nutrient intakes from DSs. The DSID provides statistical tools on the basis of the results of chemical analysis to convert label claims into analytically predicted ingredient amounts. These adjustments to labels are linked to DS products reported in NHANES., Rationale: Tables summarizing the numbers of NHANES DS products with ingredient overages and below label content show the importance of DSID adjustments to labels for accurate intake calculations., Recent Developments: We show the differences between analytically based estimates and labeled content for vitamin D, calcium, iodine, caffeine, and omega-3 (n-3) fatty acids and their potential impact on the accuracy of intake assessments in large surveys. Analytical overages >20% of label levels are predicted for several nutrients in 50-99% of multivitamin-mineral products (MVMs) reported in NHANES: for iodine and selenium in adult MVMs, for iodine and vitamins D and E in children's MVMs, and for iodine, chromium, and potassium in nonprescription prenatal MVMs. Predicted overages of 10-20% for calcium can be applied to most MVMs and overages >10% for folic acid in the vast majority of adult and children's MVMs., Future Directions: DSID studies are currently evaluating ingredient levels in prescription prenatal MVMs and levels of constituents in botanical DSs., Conclusions: We estimate that the majority of MVM products reported in NHANES have significant overages for several ingredients. It is important to account for nonlabeled additional nutrient exposure from DSs to better evaluate nutritional status in the United States., (© Crown copyright 2018.)
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- 2018
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9. The Dietary Supplement Label Database: Recent Developments and Applications.
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Dwyer JT, Bailen RA, Saldanha LG, Gahche JJ, Costello RB, Betz JM, Davis CD, Bailey RL, Potischman N, Ershow AG, Sorkin BC, Kuszak AJ, Rios-Avila L, Chang F, Goshorn J, Andrews KW, Pehrsson PR, Gusev PA, Harnly JM, Hardy CJ, Emenaker NJ, and Herrick KA
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- Humans, United States, Commerce, Databases, Factual, Dietary Supplements, Information Dissemination, Product Labeling
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Objective: To describe the history, key features, recent enhancements, and common applications of the Dietary Supplement Label Database (DSLD)., Background and History: Although many Americans use dietary supplements, databases of dietary supplements sold in the United States have not been widely available. The DSLD, an easily accessible public-use database was created in 2008 to provide information on dietary supplement composition for use by researchers and consumers., Rationale: Accessing current information easily and quickly is crucial for documenting exposures to dietary supplements because they contain nutrients and other bioactive ingredients that may have beneficial or adverse effects on human health. This manuscript details recent developments with the DSLD to achieve this goal and provides examples of how the DSLD has been used., Recent Developments: With periodic updates to track changes in product composition and capture new products entering the market, the DSLD currently contains more than 71,000 dietary supplement labels. Following usability testing with consumer and researcher user groups completed in 2016, improvements to the DSLD interface were made. As of 2017, both a desktop and mobile device version are now available. Since its inception in 2008, the use of the DSLD has included research, exposure monitoring, and other purposes by users in the public and private sectors., Future Directions: Further refinement of the user interface and search features to facilitate ease of use for stakeholders is planned., Conclusions: The DSLD can be used to track changes in product composition and capture new products entering the market. With over 71,000 DS labels it is a unique resource that policymakers, researchers, clinicians, and consumers may find valuable for multiple applications., Competing Interests: Conflicts of interest: JT Dwyer, RA Bailen, L Saldanha, J Gahche, R Costello, JM Betz, Cindy Davis, RL Bailey, N Potischman, A Ershow, B Sorkin, A Kuszak,L Rios-Avila, F Chang, J Goshorn, K Andrews, P Pehrsson, P Gusev, J Harnly, CJ Hardy, N Emenaker, KA Herrick, no conflicts of interest.
- Published
- 2018
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10. Characteristics and Challenges of Dietary Supplement Databases Derived from Label Information.
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Saldanha LG, Dwyer JT, Bailen RA, Andrews KW, Betz JW, Chang HF, Costello RB, Ershow AG, Goshorn J, Hardy CJ, and Coates PM
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- Humans, Legislation, Food, United States, United States Food and Drug Administration, Databases, Factual, Dietary Supplements analysis, Food Labeling legislation & jurisprudence, Food Labeling standards, Food Labeling statistics & numerical data
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Launched in 2008, the Dietary Supplement Label Database (DSLD) permits the search of any term that appears anywhere on product labels. Since then, the database's search and download features have been periodically improved to enhance use for researchers and consumers. In this review, we describe how to customize searches and identify products and ingredients of interest to users in the DSLD, and provide the limitations of working with information derived from dietary supplement product labels. This article describes how data derived from information printed on product labels are entered and organized in the DSLD. Among the challenges are determining the chemical forms, types of extract, and amounts of dietary ingredients, especially when these are components of proprietary blends. The FDA announced new dietary supplement labeling regulations in May 2016. The 2017 DSLD has been updated to reflect them. These new regulations and examples cited in this article refer to this redesigned version of the DSLD. Search selection characteristics such as for product type and intended user group are as described in FDA guidance and regulations for dietary supplements. For this reason, some age groups (such as teens and seniors) and marketing recommendations for use (e.g., weight loss, performance, and other disease- or condition-specific claims) are not included in the search selections. The DSLD user interface features will be revised periodically to reflect regulatory and technologic developments to enhance user experience. A comprehensive database derived from analytically verified data on composition would be preferable to label data, but is not feasible for technical, logistic, and financial reasons. Therefore, a database derived from information printed on product labels is the only practical option at present for researchers, clinicians, and consumers interested in the composition of these products., (© Crown copyright 2018.)
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- 2018
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11. Challenges in Developing Analytically Validated Laboratory-Derived Dietary Supplement Databases.
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Betz JM, Rimmer CA, Saldanha LG, Phillips MM, Andrews KW, Wise SA, Wood LJ, Kuszak AJ, Gusev PA, and Pehrsson PR
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- Dietary Supplements adverse effects, Dietary Supplements standards, Food Labeling, Humans, Laboratories, Minerals analysis, Minerals standards, National Institutes of Health (U.S.), National Library of Medicine (U.S.), Public Health, Reference Standards, Tea chemistry, Tea standards, United States, United States Department of Agriculture, Vitamins analysis, Vitamins standards, Databases, Factual, Dietary Supplements analysis
- Abstract
The Dietary Supplement Label Database (DSLD) is sponsored by the Office of Dietary Supplements (ODS) and the National Library of Medicine (NLM). It provides a searchable, free database of the contents of ∼65,000 supplement labels. A companion database of analytically verified product labels [the Dietary Supplement Ingredient Database (DSID)] was created by ODS, NLM, and the USDA. There are considerable challenges to populating both databases, but the DSID faces unique analytic chemistry challenges. This article describes the challenges to creating analytically verified marketplace surveys of dietary supplement (DS) product content claims for inclusion in public databases. Nutritionists and public health scientists require information on actual exposures to DS constituents because labeled content may not match labeled product content. Analytic verification of composition of DSs provides a link to actual exposure. A public database of analytically derived DS content was developed to provide more accurate estimates of dietary intake in population-based epidemiologic studies. The DSID has conducted surveys of several types of vitamin- and mineral-containing DSs. Results showing label content claims as analytically derived values are available in the current DSID. A recent pilot project explored the feasibility of adding botanical DS products to the DSID. Candidates for future botanical DSID studies will be based on sales volume, potential public health impacts, and the availability of validated analytic methods and reference materials. Databases like DSID and the DSLD are essential for researchers and clinicians to evaluate dietary ingredient intakes in population-based epidemiologic studies. Together, these databases provide a picture of the DS marketplace. The DSID provides an analytic survey of marketed DSs. However, selection of future botanical supplements for DSID evaluation involves analytic challenges. Even when appropriate resources are available, method selection and data evaluation are resource- and time-consuming., (© Crown copyright 2018.)
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- 2018
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12. Is Nutrient Content and Other Label Information for Prescription Prenatal Supplements Different from Nonprescription Products?
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Saldanha LG, Dwyer JT, Andrews KW, Brown LL, Costello RB, Ershow AG, Gusev PA, Hardy CJ, and Pehrsson PR
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- Databases, Factual, Drug Labeling methods, Female, Food Labeling methods, Humans, Nutritive Value, Pregnancy, Prenatal Care, Prenatal Nutritional Physiological Phenomena, Recommended Dietary Allowances, United States, Dietary Supplements standards, Drug Labeling standards, Food Labeling standards, Nonprescription Drugs standards, Prescription Drugs standards
- Abstract
Background: Prenatal supplements are often recommended to pregnant women to help meet their nutrient needs. Many products are available, making it difficult to choose a suitable supplement because little is known about their labeling and contents to evaluate their appropriateness., Objective: To determine differences between prescription and nonprescription prenatal supplements available in the United States regarding declared nutrient and nonnutrient ingredients and the presence of dosing and safety-related information., Design: Using two publicly available databases with information about prenatal supplement products, information from prescription and nonprescription product labels were extracted and evaluated. For the 82 prescription and 132 nonprescription products, declared label amounts of seven vitamins and minerals, docosahexaenoic acid (DHA), the presence of other nonnutrient components, and the presence of key safety and informational elements as identified in two Department of Health and Human Services Office of Inspector General (OIG)'s 2003 reports were compiled and compared., Results: Compared with nonprescription products, prescription products contained significantly fewer vitamins (9±0.2 vs 11±0.3; P≤0.05) and minerals (4±0.1 vs 8±0.3; P≤0.05). Declared amounts of folic acid were higher in prescription products, whereas vitamin A, vitamin D, iodine, and calcium were higher in the nonprescription products. Amounts of iron, zinc, and DHA were similar. Virtually all products contained levels of one or more nutrients that exceeded the Recommended Dietary Allowances for pregnant and/or lactating women. Product type also influenced ingredients added. Fewer prescription products contained botanical ingredients (6% prescription vs 33% nonprescription) and probiotics (2% prescription vs 8% nonprescription). Only prescription products contained the stool softener docusate sodium., Conclusions: Our analysis of prenatal supplements indicates that prescription and nonprescription supplements differ in terms of declared composition and nutrient strength, but have labels that are similarly sparse regarding aspects of use such as dosing information., (Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)
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- 2017
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13. Analytical ingredient content and variability of adult multivitamin/mineral products: national estimates for the Dietary Supplement Ingredient Database.
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Andrews KW, Roseland JM, Gusev PA, Palachuvattil J, Dang PT, Savarala S, Han F, Pehrsson PR, Douglass LW, Dwyer JT, Betz JM, Saldanha LG, and Bailey RL
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- Adult, Female, Humans, Linear Models, Male, Nutrition Surveys, Quality Control, Recommended Dietary Allowances, Reproducibility of Results, Dietary Supplements, Micronutrients analysis, Trace Elements analysis, Vitamins analysis
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Background: Multivitamin/mineral products (MVMs) are the dietary supplements most commonly used by US adults. During manufacturing, some ingredients are added in amounts exceeding the label claims to compensate for expected losses during the shelf life. Establishing the health benefits and harms of MVMs requires accurate estimates of nutrient intake from MVMs based on measures of actual rather than labeled ingredient amounts., Objectives: Our goals were to determine relations between analytically measured and labeled ingredient content and to compare adult MVM composition with Recommended Dietary Allowances (RDAs) and Tolerable Upper Intake Levels., Design: Adult MVMs were purchased while following a national sampling plan and chemically analyzed for vitamin and mineral content with certified reference materials in qualified laboratories. For each ingredient, predicted mean percentage differences between analytically obtained and labeled amounts were calculated with the use of regression equations., Results: For 12 of 18 nutrients, most products had labeled amounts at or above RDAs. The mean measured content of all ingredients (except thiamin) exceeded labeled amounts (overages). Predicted mean percentage differences exceeded labeled amounts by 1.5-13% for copper, manganese, magnesium, niacin, phosphorus, potassium, folic acid, riboflavin, and vitamins B-12, C, and E, and by ∼25% for selenium and iodine, regardless of labeled amount. In contrast, thiamin, vitamin B-6, calcium, iron, and zinc had linear or quadratic relations between the labeled and percentage differences, with ranges from -6.5% to 8.6%, -3.5% to 21%, 7.1% to 29.3%, -0.5% to 16.4%, and -1.9% to 8.1%, respectively. Analytically adjusted ingredient amounts are linked to adult MVMs reported in the NHANES 2003-2008 via the Dietary Supplement Ingredient Database (http://dsid.usda.nih.gov) to facilitate more accurate intake quantification., Conclusions: Vitamin and mineral overages were measured in adult MVMs, most of which already meet RDAs. Therefore, nutrient overexposures from supplements combined with typical food intake may have unintended health consequences, although this would require further examination., (© 2017 American Society for Nutrition.)
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- 2017
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14. Iodine in food- and dietary supplement-composition databases.
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Pehrsson PR, Patterson KY, Spungen JH, Wirtz MS, Andrews KW, Dwyer JT, and Swanson CA
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- Humans, Internet, Iodine administration & dosage, United States, United States Department of Agriculture, Databases, Factual, Diet, Dietary Supplements, Food Analysis methods, Iodine analysis
- Abstract
The US Food and Drug Administration (FDA) and the Nutrient Data Laboratory (NDL) of the USDA Agricultural Research Service have worked independently on determining the iodine content of foods and dietary supplements and are now harmonizing their efforts. The objective of the current article is to describe the harmonization plan and the results of initial iodine analyses accomplished under that plan. For many years, the FDA's Total Diet Study (TDS) has measured iodine concentrations in selected foods collected in 4 regions of the country each year. For more than a decade, the NDL has collected and analyzed foods as part of the National Food and Nutrient Analysis Program; iodine analysis is now being added to the program. The NDL recently qualified a commercial laboratory to conduct iodine analysis of foods by an inductively coupled plasma mass spectrometry (ICP-MS) method. Co-analysis of a set of samples by the commercial laboratory using the ICP-MS method and by the FDA laboratory using its standard colorimetric method yielded comparable results. The FDA recently reviewed historical TDS data for trends in the iodine content of selected foods, and the NDL analyzed samples of a limited subset of those foods for iodine. The FDA and the NDL are working to combine their data on iodine in foods and to produce an online database that can be used for estimating iodine intake from foods in the US population. In addition, the NDL continues to analyze dietary supplements for iodine and, in collaboration with the NIH Office of Dietary Supplements, to publish the data online in the Dietary Supplement Ingredient Database. The goal is to provide, through these 2 harmonized databases and the continuing TDS focus on iodine, improved tools for estimating iodine intake in population studies., (© 2016 American Society for Nutrition.)
- Published
- 2016
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15. Interlaboratory Trial for Measurement of Vitamin D and 25-Hydroxyvitamin D [25(OH)D] in Foods and a Dietary Supplement Using Liquid Chromatography-Mass Spectrometry.
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Roseland JM, Patterson KY, Andrews KW, Phillips KM, Phillips MM, Pehrsson PR, Dufresne GL, Jakobsen J, Gusev PA, Savarala S, Nguyen QV, Makowski AJ, Scheuerell CR, Larouche GP, Wise SA, Harnly JM, Williams JR, Betz JM, and Taylor CL
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- Vitamin D analysis, Chromatography, Liquid methods, Dietary Supplements analysis, Food Analysis, Tandem Mass Spectrometry methods, Vitamin D analogs & derivatives
- Abstract
Assessment of total vitamin D intake from foods and dietary supplements (DSs) may be incomplete if 25-hydroxyvitamin D [25(OH)D] intake is not included. However, 25(OH)D data for such intake assessments are lacking, no food or DS reference materials (RMs) are available, and comparison of laboratory performance has been needed. The primary goal of this study was to evaluate whether vitamin D3 and 25(OH)D3 concentrations in food and DS materials could be measured with acceptable reproducibility. Five experienced laboratories from the United States and other countries participated, all using liquid chromatography tandem-mass spectrometry but no common analytical protocol; however, various methods were used for determining vitamin D3 in the DS. Five animal-based materials (including three commercially available RMs) and one DS were analyzed. Reproducibility results for the materials were acceptable. Thus, it is possible to obtain consistent results among experienced laboratories for vitamin D3 and 25(OH)D3 in foods and a DS.
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- 2016
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16. A free new dietary supplement label database for registered dietitian nutritionists.
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Dwyer JT, Saldanha LG, Bailen RA, Bailey RL, Costello RB, Betz JM, Chang FF, Goshorn J, Andrews KW, Pehrsson PR, Milner JA, Burt VL, Gahche JJ, Hardy CJ, and Emenaker NJ
- Subjects
- Dietary Supplements adverse effects, Education, Continuing, Humans, Internet, National Library of Medicine (U.S.), Nutrition Surveys, Nutritionists education, United States, Databases, Factual, Dietary Supplements analysis, Food Labeling
- Published
- 2014
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17. Variability in vitamin D content among products for multivitamin and mineral supplements.
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Andrews KW, Pehrsson PR, and Betz JM
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- Drug Compounding standards, Nonprescription Drugs standards, Vitamin D standards
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- 2013
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18. Summary of an NIH workshop to identify research needs to improve the monitoring of iodine status in the United States and to inform the DRI.
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Swanson CA, Zimmermann MB, Skeaff S, Pearce EN, Dwyer JT, Trumbo PR, Zehaluk C, Andrews KW, Carriquiry A, Caldwell KL, Egan SK, Long SE, Bailey RL, Sullivan KM, Holden JM, Betz JM, Phinney KW, Brooks SP, Johnson CL, and Haggans CJ
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- Adolescent, Adult, Canada, Child, Child, Preschool, Female, Humans, Hypothyroidism epidemiology, Infant, Infant, Newborn, Lactation, National Institutes of Health (U.S.), Nutrition Policy, Pregnancy, United States, Young Adult, Iodine blood, Iodine deficiency, Research
- Abstract
The Office of Dietary Supplements (ODS) at the NIH sponsored a workshop on May 12-13, 2011, to bring together representatives from various NIH institutes and centers as a first step in developing an NIH iodine research initiative. The workshop also provided an opportunity to identify research needs that would inform the dietary reference intakes for iodine, which were last revised in 2001. Iodine is required throughout the life cycle, but pregnant women and infants are the populations most at risk of deficiency, because iodine is required for normal brain development and growth. The CDC monitors iodine status of the population on a regular basis, but the status of the most vulnerable populations remains uncertain. The NIH funds very little investigator-initiated research relevant to iodine and human nutrition, but the ODS has worked for several years with a number of other U.S. government agencies to develop many of the resources needed to conduct iodine research of high quality (e.g., validated analytical methods and reference materials for multiple types of samples). Iodine experts, scientists from several U.S. government agencies, and NIH representatives met for 2 d to identify iodine research needs appropriate to the NIH mission.
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- 2012
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19. A structured vocabulary for indexing dietary supplements in databases in the United States.
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Saldanha LG, Dwyer JT, Holden JM, Ireland JD, Andrews KW, Bailey RL, Gahche JJ, Hardy CJ, Møller A, Pilch SM, and Roseland JM
- Abstract
Food composition databases are critical to assess and plan dietary intakes. Dietary supplement databases are also needed because dietary supplements make significant contributions to total nutrient intakes. However, no uniform system exists for classifying dietary supplement products and indexing their ingredients in such databases. Differing approaches to classifying these products make it difficult to retrieve or link information effectively. A consistent approach to classifying information within food composition databases led to the development of LanguaL™, a structured vocabulary. LanguaL™ is being adapted as an interface tool for classifying and retrieving product information in dietary supplement databases. This paper outlines proposed changes to the LanguaL™ thesaurus for indexing dietary supplement products and ingredients in databases. The choice of 12 of the original 14 LanguaL™ facets pertinent to dietary supplements, modifications to their scopes, and applications are described. The 12 chosen facets are: Product Type; Source; Part of Source; Physical State, Shape or Form; Ingredients; Preservation Method, Packing Medium, Container or Wrapping; Contact Surface; Consumer Group/Dietary Use/Label Claim; Geographic Places and Regions; and Adjunct Characteristics of food.
- Published
- 2012
- Full Text
- View/download PDF
20. Online dietary supplement resources.
- Author
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Saldanha LG, Dwyer JT, Andrews KW, Bailey RL, Gahche JJ, Hardy CJ, Holden JM, Picciano MF, Roseland JM, Thomas PR, and Wolf WR
- Subjects
- Commerce, Databases, Factual, Humans, National Institutes of Health (U.S.), United States, Dietary Supplements standards, Dietetics, Drug Information Services standards, Information Dissemination, Internet statistics & numerical data
- Published
- 2010
- Full Text
- View/download PDF
21. Dietary supplement ingredient database (DSID): Preliminary USDA studies on the composition of adult multivitamin/mineral supplements.
- Author
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Roseland JM, Holden JM, Andrews KW, Zhao C, Schweitzer A, Harnly J, Wolf WR, Perry CR, Dwyer JT, Picciano MF, Betz JM, Saldanha LG, Yetley EA, Fisher KD, and Sharpless KE
- Abstract
The Nutrient Data Laboratory of the United States Department of Agriculture (USDA) is collaborating with the Office of Dietary Supplements (ODS), the National Center for Health Statistics (NCHS), and other government agencies to design and populate a dietary supplement ingredient database (DSID). This analytically based, publicly available database will provide reliable estimates of vitamin and mineral content of dietary supplement (DS) products. The DSID will initially be populated with multivitamin/mineral (MVM) products because they are the most commonly consumed supplements. Challenges associated with the analysis of MVMs were identified and investigated. A pilot study addressing the identification of appropriate analytical methods, sample preparation protocols, and experienced laboratories for the analysis of 12 vitamins and 11 minerals in adult MVM supplement products was completed. Preliminary studies support the development of additional analytical studies with results that can be applied to the DSID. Total intakes from foods and supplements are needed to evaluate the associations between dietary components and health. The DSID will provide better estimates of actual nutrient intake from supplements than databases that rely on label values alone.
- Published
- 2008
- Full Text
- View/download PDF
22. The caffeine contents of dietary supplements commonly purchased in the US: analysis of 53 products with caffeine-containing ingredients.
- Author
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Andrews KW, Schweitzer A, Zhao C, Holden JM, Roseland JM, Brandt M, Dwyer JT, Picciano MF, Saldanha LG, Fisher KD, Yetley E, Betz JM, and Douglass L
- Subjects
- Quality Control, United States, Caffeine analysis, Dietary Supplements analysis, Food Analysis
- Abstract
As part of a study initiating the development of an analytically validated Dietary Supplement Ingredient Database (DSID) in the United States (US), a selection of dietary supplement products were analyzed for their caffeine content. Products sold as tablets, caplets, or capsules and listing at least one caffeine-containing ingredient (including botanicals such as guarana, yerba mate, kola nut, and green tea extract) on the label were selected for analysis based on market share information. Two or three lots of each product were purchased and analyzed using high-pressure liquid chromatography (HPLC). Each analytical run included one or two National Institute of Standards and Technology (NIST) Standard Reference Materials (SRMs) and two products in duplicate. Caffeine intake per serving and per day was calculated using the maximum recommendations on each product label. Laboratory analysis for 53 products showed product means ranging from 1 to 829 mg caffeine/day. For products with a label amount for comparison (n = 28), 89% (n = 25) of the products had analytically based caffeine levels/day of between -16% and +16% of the claimed levels. Lot-to-lot variability (n = 2 or 3) for caffeine in most products (72%) was less than 10%.
- Published
- 2007
- Full Text
- View/download PDF
23. Brain cancer risk and electromagnetic fields (EMFs): assessing the geomagnetic component.
- Author
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Aldrich TE, Andrews KW, and Liboff AR
- Subjects
- Aged, Case-Control Studies, Cluster Analysis, Confounding Factors, Epidemiologic, Cyclotrons, Databases, Factual, Environmental Exposure analysis, Environmental Monitoring, Epidemiological Monitoring, Female, Geography, Humans, Incidence, Information Systems, Logistic Models, Male, Middle Aged, North Carolina epidemiology, Population Surveillance, Predictive Value of Tests, Residence Characteristics statistics & numerical data, Risk Factors, Brain Neoplasms epidemiology, Brain Neoplasms etiology, Electromagnetic Fields adverse effects, Environmental Exposure adverse effects, Power Plants
- Abstract
Cancer cluster studies in North Carolina identified several communities in which there existed an elevated risk of brain cancer. These findings prompted a series of case-control studies. The current article, which originated from the results of the 3rd of such studies, is focused on inclusion of the earth's own geomagnetic fields that interact with electromagnetic fields generated from distribution power lines. This article also contains an assessment of the contribution of confounding by residential (e.g., urban, rural) and case characteristics (e.g., age, race, gender). Newly diagnosed brain cancer cases were identified for a 4-county region of central North Carolina, which the authors chose on the basis of the results of earlier observations. A 3:1 matched series of cancer cases from the same hospitals in which the cases were diagnosed served as the comparison group. Extensive geographic information was collected and was based on an exact place of residence at the time of cancer diagnosis, thus providing several strategic geophysical elements for assessment. The model for this assessment was based on the effects of these two sources of electromagnetic fields for an ion cyclotron resonance mechanism of disease risk. The authors used logistic regression models that contained the predicted value for the parallel component of the earth's magnetic field; these models were somewhat erratic, and the elements were not merged productively into a single statistical model. Interpretation of these values was difficult; therefore, the modeled values for the model elements, at progressive distances from the nearest power-line segments, are provided. The results of this study demonstrate the merits of using large, population-based databases, as well as using rigorous Geographic Information System techniques, for the assessment of ecologic environmental risks. The results also suggest promise for exposure classification that is compatible with the theoretical biological mechanisms posited for electromagnetic fields.
- Published
- 2001
- Full Text
- View/download PDF
24. Accuracy of industry and occupation on death certificates of electric utility workers: implications for epidemiologic studies of magnetic fields and cancer.
- Author
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Andrews KW and Savitz DA
- Subjects
- Adult, Aged, Aged, 80 and over, Brain Neoplasms epidemiology, Brain Neoplasms mortality, Cause of Death, Confidence Intervals, Humans, Leukemia epidemiology, Leukemia mortality, Lung Neoplasms epidemiology, Lung Neoplasms mortality, Middle Aged, Neoplasms etiology, Neoplasms mortality, Odds Ratio, Reproducibility of Results, Social Class, United States epidemiology, Death Certificates, Electricity, Electromagnetic Fields, Neoplasms epidemiology, Occupational Exposure
- Abstract
A substantial epidemiologic literature has relied on occupation and industry information from death certificates to make inferences about the association of electric and magnetic field exposure with cancer, but the validity of the occupational data on death certificates is questionable. We compared occupation and industry information from death certificates to company work histories for 793 electric utility workers who died from brain cancer (n=143), leukemia (n=156), lung cancer (n=246, randomly sampled), and non-cancer causes (n=248, randomly sampled). Nearly 75% of death certificates correctly indicated utility industry employment and of those, 48% matched the longest held occupation derived from company work histories. Hence, only 36% matched on both industry and occupation. We computed odds ratios relating occupations involving magnetic field exposure to brain cancer and leukemia both for the occupation listed on the death certificate and for the longest-held occupation based on company records in order to examine the impact of exposure misclassification based on reliance on the death certificate information. For brain cancer, the odds ratio was 1.2 based on death certificates and 1.7 based on company work history, suggesting some attenuation due to misclassification. For leukemia, death certificate information yielded an odds ratio of 0.9, whereas company work histories yielded an odds ratio of 1.3. Although work histories are limited to the period of employment in a specific company, these data suggest that there is substantial misclassification in use of death certificate information on industry and occupation of utility workers, as found in other industries. The limited quality of occupation and industry information on death certificates argues against relying on such information to evaluate modest associations with mortality., (Copyright 1999 Wiley-Liss, Inc.)
- Published
- 1999
- Full Text
- View/download PDF
25. Review of epidemiologic evidence on benzene and lymphatic and hematopoietic cancers.
- Author
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Savitz DA and Andrews KW
- Subjects
- Humans, Leukemia chemically induced, Leukemia epidemiology, Lymphoma chemically induced, Lymphoma epidemiology, Benzene adverse effects, Hematologic Neoplasms chemically induced, Hematologic Neoplasms epidemiology
- Abstract
Exposure to benzene is generally accepted as a cause of acute myeloid leukemia (AML), but the association with other cell types of leukemia and other lymphatic and hematopoietic cancers is controversial. We compiled epidemiologic research on benzene and lymphatic and hematopoietic cancers in order to assess the pattern of associations. Eighteen relevant community-based and 16 industry-based studies were located. Four of seven studies of lymphatic and hematopoietic cancer in the aggregate identified relative risks of 1.8 or more, and eight of 14 total leukemia studies yielded relative risks in that range. The few available studies of specific histologic types of leukemia do not indicate larger or more consistent elevations in risk for AML compared to other leukemia cell types. Sporadic reports have linked benzene to non-Hodgkin's lymphoma and multiple myeloma, but most studies do not indicate a positive association. Limitations in study quality, particularly exposure assessment, pervade all of the studies reviewed, and the distinction between studies addressing benzene and those addressing jobs in industries that use benzene is somewhat arbitrary. Nonetheless, the epidemiologic evidence linking benzene to leukemia in the aggregate, as well as for subtypes other than AML, is no less persuasive than that for AML alone.
- Published
- 1997
- Full Text
- View/download PDF
26. Risk of myelogenous leukaemia and multiple myeloma in workers exposed to benzene.
- Author
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Savitz DA and Andrews KW
- Subjects
- Humans, Risk Factors, Benzene adverse effects, Carcinogens adverse effects, Leukemia, Myeloid chemically induced, Multiple Myeloma chemically induced, Occupational Diseases chemically induced
- Published
- 1996
27. Drinking water and pregnancy outcome in central North Carolina: source, amount, and trihalomethane levels.
- Author
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Savitz DA, Andrews KW, and Pastore LM
- Subjects
- Case-Control Studies, Dose-Response Relationship, Drug, Evaluation Studies as Topic, Female, Humans, North Carolina epidemiology, Pregnancy, Risk Factors, Chlorofluorocarbons, Methane adverse effects, Fresh Water chemistry, Pregnancy Outcome epidemiology, Water Pollutants, Chemical adverse effects
- Abstract
In spite of the recognition of potentially toxic chemicals in chlorinated drinking water, few studies have evaluated reproductive health consequences of such exposure. Using data from a case-control study of miscarriage, preterm delivery, and low birth weight in central North Carolina, we evaluated risk associated with water source, amount, and trihalomethane (THM) concentration. Water source was not related to any of those pregnancy outcomes, but an increasing amount of ingested water was associated with decreased risks of all three outcomes (odds ratios around 1.5 for 0 glasses per day relative to 1-3 glasses per day, falling to 0.8 for 4+ glasses per day). THM concentration and dose (concentration x amount) were not related to pregnancy outcome, with the possible exception of an increased risk of miscarriage in the highest sextile of THM concentration (adjusted odds ratio = 2.8, 95% confidence interval = 1.1-2.7), which was not part of an overall dose-response gradient. These data do not indicate a strong association between chlorination by-products and adverse pregnancy outcome, but given the limited quality of our exposure assessment and the increased miscarriage risk in the highest exposure group, more refined evaluation is warranted.
- Published
- 1995
- Full Text
- View/download PDF
28. Occupation and cervical cancer.
- Author
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Savitz DA, Andrews KW, and Brinton LA
- Subjects
- Adult, Aged, Case-Control Studies, Female, Humans, Middle Aged, Odds Ratio, United States epidemiology, Carcinoma in Situ epidemiology, Occupational Diseases epidemiology, Uterine Cervical Neoplasms epidemiology, Women, Working
- Abstract
Data collected for a multicenter case-control study of invasive cervical cancer and carcinoma in situ of the cervix were analyzed with regard to occupation. Odds ratios comparing 481 invasive cases and 293 carcinoma in situ cases to 801 controls were calculated and adjusted for potential confounding factors. Working women and homemakers had a similar risk of invasive cervical cancer, with several groups of service and industrial workers showing elevated risks (particularly maids, cleaners, and cooks). Risk of carcinoma in situ was slightly increased for working women, but no occupational groups had notable associations. The principal strengths of this analysis were the ability to address both invasive cervical cancer and carcinoma in situ and to control for multiple potential confounding factors. However, occupational information was limited and risk estimates for women in specific occupations were imprecise.
- Published
- 1995
- Full Text
- View/download PDF
29. Prenatal lead exposure in relation to gestational age and birth weight: a review of epidemiologic studies.
- Author
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Andrews KW, Savitz DA, and Hertz-Picciotto I
- Subjects
- Confounding Factors, Epidemiologic, Epidemiologic Methods, Female, Fetal Membranes, Premature Rupture chemically induced, Humans, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Lead toxicity, Pregnancy, Pregnancy Outcome, Prenatal Exposure Delayed Effects, Birth Weight drug effects, Fetal Diseases chemically induced, Gestational Age, Lead adverse effects
- Abstract
Although the adverse effect on pregnancy outcomes at high levels of lead exposure in the workplace has been recognized for years, there is uncertainty regarding the impact of exposure at the lower community exposure levels commonly encountered today. This review summarizes the epidemiologic literature and discusses pertinent methodologic issues and possible sources of interstudy variation. The authors conclude that prenatal lead exposure is unlikely to increase the risk of premature membrane rupture but does appear to increase the risk of preterm delivery. Whether prenatal lead exposure decreases gestational age in terms of infants is unclear. Prenatal lead exposure also appears to be associated with reduced birth weight, but results vary in relation to study design and degree of control for confounding. Adjustment for gestational age, a possible confounder of the birth weight-lead exposure association, did not yield clearer results.
- Published
- 1994
- Full Text
- View/download PDF
30. Simplified method for determination of total dietary fiber in foods.
- Author
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Li BW and Andrews KW
- Subjects
- Indicators and Reagents, Dietary Fiber analysis, Food Analysis
- Abstract
A simplified method, based on the same principles as the AOAC enzymatic-gravimetric method for determining total dietary fiber (TDF) (43.A14-43.A20), has been tested on 12 food samples which had been used in other collaborative studies. TDF values obtained in our laboratory for these 2 methods were in good agreement (y = 0.96x + 0.39; r = 0.999). The simplified method uses a single incubation period and only 1 enzyme (amyloglucosidase), and thus yields smaller blank and ash corrections but a higher protein correction.
- Published
- 1988
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