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Mitigation options to reduce the risk of foreign animal disease entry into the United States may lead to degradation of some vitamins. The objective of Exp. 1 was to determine the impact of 0, 30, 60, or 90 d storage time on water-soluble vitamin (riboflavin, niacin, pantothenic acid, and cobalamin) stability when vitamin premix (VP) and vitamin trace mineral premix (VTM) were blended with 1% inclusion of medium-chain fatty acid (MCFA) (1:1:1 blend of C6:C8:C10) or mineral oil (MO) with different environmental conditions. Samples stored at room temperature (RT) (approximately 22 °C) or in an environmentally controlled chamber set at 40 °C and 75% humidity, high temperature high humidity (HTHH). The sample bags were pulled out at day 0, 30, 60, and 90 for RT condition and HTHH condition. Therefore, treatments were analyzed as a 2 × 2 × 2 × 3 factorial, with two premix types (vitamin premix vs. VTM), two oil types (MO vs. MCFA), two storage conditions (RT vs. HTHH), and three time points (day 30, 60, and 90). The objective of Exp. 2 was to determine the effect of heat pulse treatment and MCFA addition on water-soluble vitamin (riboflavin, niacin, pantothenic acid, and cobalamin) stability with two premix types. A sample from each treatment was heated at 60 °C and 20% humidity. Therefore, treatments were analyzed as a 2 × 2 factorial, with two premix types (VP vs. VTM) and two oil types (MO vs. MCFA). For Exp. 1, the following effects were significant for riboflavin: main effect of premix type (P < 0.0001), storage condition (P = 0.015), and storage time (P < 0.0001); for pantothenic acid: premix type × storage time × storage condition (P = 0.003) and premix type × oil type (P < 0.0001) interactions; and for cobalamin: premix type × storage condition (P < 0.0001) and storage time × storage condition (P < 0.0001) interactions and main effect of oil type (P = 0.018). The results of Exp. 2 demonstrated that there was an interaction between oil type and premix type for only pantothenic acid (P = 0.021). The oil type did not affect the stability of riboflavin, niacin, or cobalamin and pantothenic acid stability was not different within similar premixes. The only difference in water-soluble vitamin stability between VP and VTM was for pantothenic acid (P < 0.001). The results of this experiment demonstrated that the stability of water soluble vitamins are dependent on the vitamin of interest and the conditions at which it is stored. [ABSTRACT FROM AUTHOR]

Introduction: We assessed the efficacy and safety of OPF-105, a novel all-in-one peripheral parenteral nutrition (PPN) solution containing multivitamins by the U.S. Food and Drug Administration in 2000 (FDA2000 recommendation). Methods: We conducted a phase III trial administering OPF-105 or BFL (combination of a commercially available PPN solution and fat emulsion) to patients after gastrointestinal (GI) tract surgery from postoperative day (POD) 1 up to POD14. Until POD7, nutrients were provided only with OPF-105 or BFL. After blood sampling on POD8, oral food intake was permitted. PPN was administered according to the amount of food intake. Results: Efficacy endpoints were assessed in 99 subjects (OPF group: 52; BFL group: 47). The levels of blood proteins and fatty acids in the two groups were similar on POD8. The transition of these mean levels was similar in both groups from POD1 or 2 to POD9 to 15. The mean preoperative blood vitamin levels were within reference intervals (RIs). On POD1 (before administration), the mean levels of most blood vitamins decreased compared to those of the preoperative levels. In the BFL group, the mean blood levels of vitamin B2, B6, pantothenic acid (PA), folic acid (FA), biotin, and C decreased below or near the lower limit of RIs on POD8, and the mean blood levels of vitamin B6 and C remained low from POD9 to 15. In the OPF group, the mean blood levels of vitamins, excluding vitamin K, were within RIs on POD8 and POD9 to 15. The mean levels of blood vitamin K increased over the upper limit of RIs on POD8 but within RIs from POD9 to 15. There was no obvious difference in the incidence of adverse events between the two groups, which is common after GI tract surgeries. Conclusion: Blood vitamin levels decreased when patients were administered PPN without vitamin supplementation during the first week after surgery. The novel PPN formula containing multivitamins recommended by FDA2000 can be safely administered to postoperative patients to maintain blood vitamin levels. [ABSTRACT FROM AUTHOR]

Nearly a third of young US children take multivitamin/mineral (MVM) dietary supplements, yet it is unclear how formulations compare with requirements. Describe the number and amounts of micronutrients contained in MVMs for young children and compare suggested amounts on product labels to micronutrient requirements. Cross-sectional. 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. 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. Number of products and percent DV per day provided by each micronutrient in each product. 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 , B 12 ; 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. A reexamination of the amounts and types of micronutrients in MVMs might consider formulations that better fill critical gaps in intakes and avoid excess. [ABSTRACT FROM AUTHOR]

Background An adequate vitamin intake is essential for a good nutritional status, especially in older women, who are more sensitive to nutritional deficiencies. The American, European and Italian Recommended Dietary Allowances (RDAs) derive mainly from studies on adults, and it is not clear whether they also apply to elderly people. Comparing the RDAs with the actual vitamin intake of a group of healthy older women could help to clarify the real needs of elderly people. Objective Our aim was to compare the American, European, and Italian RDAs with the actual vitamin intake of a group of healthy older women. Design This was a cross-sectional study. Participants The study included 286 healthy women aged older than 65 years. Main outcome measures For each micronutrient, the 50th percentile of the distribution of its intake was considered as the average requirement, and the corresponding calculated RDA for our sample was the average requirement×1.2, as recommended by the US Food and Nutrition Board. This calculated RDA was then compared with the American, European, and Italian RDAs. Statistical analyses performed Student’s t test or the Mann-Whitney test (after checking the normal distribution of the micronutrient) for continuous variables; the χ 2 test for categorical variables. Results The calculated RDA were 2,230 μg retinol equivalents for vitamin A, 2.8 μg for vitamin B-12, 0.9 mg for thiamin, 1.4 mg for riboflavin, 3.6 mg for pantothenic acid, 1.4 mg for vitamin B-6, 320 μg for folic acid, and 115 mg for vitamin C. Conclusions Our findings suggest that the current RDAs are adequate for older women’s intake of riboflavin, vitamin B-6, and folic acid, but should be raised for vitamin B-12 and for vitamin C. [ABSTRACT FROM AUTHOR]

Abstract: Safety and efficacy of a biologically active derivative of vitamin B5 (pantethine) on total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) metabolism was studied in North American subjects at conventional low to moderate cardiovascular disease (CVD) risk. A total of 120 subjects initiated a therapeutic lifestyle change (TLC) diet 4 weeks before randomization (baseline) and maintained the diet throughout a 16-week study period; at baseline, subjects were randomized in a triple-blinded manner to either pantethine (600 mg/d, baseline to week 8, and 900 mg/d, weeks 9-16) or identically labeled, nonbiologically active placebo (n = 60 per group). We hypothesized that pantethine would lower TC and low-density lipoprotein in low–CVD-risk North American subjects in a similar manner as reported in high–CVD-risk subjects studied mainly in Italy and Japan. While sustaining a TLC diet and in comparison with placebo, pantethine demonstrated significant (P < .005) and sustained reductions (from baseline to week 16) in TC (6 mg/dL, 0.16 mmol/L, 3%), LDL-C (4 mg/dL, 0.10 mmol/L, 4%), and apolipoprotein B (4 mg/dL, 0.04 g/L, 5%). Our data suggest that pantethine supplementation for 16 weeks (600 mg/d for weeks 1-8 then 900 mg/d for weeks 9-16) is safe and significantly lowers TC and LDL-C over and above the effect of TLC diet alone. Although the absolute magnitude of these effects was small in these low- to moderate-risk North Americans (4-6 mg/dL), the results are noteworthy as prior studies have shown that, for each 1 mg/dL (0.026 mmol/L) reduction in LDL-C, there is a concomitant 1% reduction in overall future CVD risk. [Copyright &y& Elsevier]

There is increased interest in accurately assessing the total dietary intake of vitamins from all sources, including foods and dietary supplements. Consequently, a Dietary Supplement Ingredient Database (DSID), based upon analytical values, is being established by USDA with support of the Office of Dietary Supplements (ODS), NIH. The DSID necessitated the development of a new SRM, 3280 — Multivitamin/Multimineral Tablets, by the National Institute of Standards and Technology (NIST), with support from the ODS. As a continuation of a long-term project to develop and validate new methods of determining water-soluble B vitamins in foods and dietary supplements, and as part of a collaborative effort with NIST to characterize SRM 3280, values for the vitamin contents of SRM 3280 have been generated by a liquid chromatographic isotope dilution mass spectrometric (LC/IDMS) method. Isotope-labeled (13C and/or 2H) B vitamins (B1-thiamine, B6-pyridoxine, B3-nicotinamide, and B5-pantothenic acid) were obtained from commercial sources, with the support of the ODS/NIH. Our LC/IDMS method uses a C18 reversed phase column, an Agilent 1100 HPLC system, and a Quattro Micro triple-quad mass spectrometer (MS). B vitamin determination was achieved using a gradient LC profile combined with MS/MS detection in multiple reaction monitoring mode. Stock solutions of the isotope-labeled vitamins were calibrated against USP standard solutions. The SRM tablets, with added amounts of the four isotope-labeled B vitamins, were extracted and the vitamins simultaneously determined in a single LC run, in contrast with the single-component determinations performed via IDMS. Unknown vitamin concentrations were calculated by comparing the ratios of the integrated LC peaks at the different masses of the unlabeled and labeled vitamins. [ABSTRACT FROM AUTHOR]

The Food and Drug Administration has redefined foods for "special dietary use". Such foods must now: (1) Supply a special dietary need that exists by reason of a physical or physiological condition, such as convalescence, a pregnancy, lactation, or by reason of a specific disease or disorder; (2) Supply a vitamin, mineral, or other dietary property to supplement diet by increasing total dietary intake; (3) Meet a special nutritional need as the sole item of the diet. The stricter definition of this category of food means that the conventional foods with added nutrients or food for which nutritional claims are made or nutritional information provided will no longer be considered as foods for special dietary uses, although they must conform to standard nutritional labeling requirements. The new regulation establishes a clearly delineated position within which the consumer, industry, and FDA can deal with special dietary foods without the past confusion as to what belonged in this category. [ABSTRACT FROM AUTHOR]