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1. Evaluation of a tablet‐based assessment tool for measuring cognition among children 4–6 years of age in Ghana

Author

Yuan, Haiying, Ocansey, Maku, Adu‐Afarwuah, Seth, Sheridan, Margaret, Hamoudi, Amar, Okronipa, Harriet, Kumordzie, Sika M, Oaks, Brietta M, and Prado, Elizabeth

Subjects
Psychology, Applied and Developmental Psychology, Clinical Research, Pediatric, Behavioral and Social Science, Mental health, Child, Child Development, Child, Preschool, Cognition, Ghana, Humans, Inhibition, Psychological, Psychometrics, cognition assessment, low- and middle-income countries, tablet tasks, Neurosciences, Cognitive Sciences, Clinical sciences, Biological psychology
Abstract

ObjectivesTo investigate several basic psychometric properties, including construct, convergent and discriminant validity, of the tablet-based Rapid Assessment of Cognitive and Emotional Regulation (RACER) among children aged 4-6 years in Ghana.MethodsWe investigated whether RACER tasks administered to children in Ghana could successfully reproduce expected patterns of performance previously found in high-income countries on similar tasks assessing inhibitory control (e.g., slower responses on inhibition trials), declarative memory (e.g., higher accuracy on previously seen items), and procedural memory (e.g., faster responses on sequence blocks). Next, we assessed the validity of declarative memory and inhibitory control scores by examining associations of these scores with corresponding paper-based test scores and increasing child age. Lastly, we examined whether RACER was more sensitive than paper-based tests to environmental risk factors common in low- and middle-income countries (LMICs).ResultsOf the 966 children enrolled, more than 96% completed the declarative memory and inhibitory control tasks; however, around 30% of children were excluded from data analysis on the procedural memory task due to missing more than half of trials. The performance of children in Ghana replicated previously documented patterns of performance. RACER inhibitory control accuracy score was significantly correlated with child age (r (929) = .09, p = .007). However, our findings did not support other hypotheses.ConclusionsThe high task completion rates and replication of expected patterns support that certain RACER sub-tasks are feasible for measuring child cognitive development in LMIC settings. However, this study did not provide evidence to support that RACER is a valid tool to capture meaningful individual differences among children aged 4-6 years in Ghana.

Published
2022

2. The impact of maternal supplementation during pregnancy and the first 6 months postpartum on the growth status of the next child born after the intervention period: Follow-up results from Bangladesh and Ghana.

Author

Adams, Katherine P, Adu-Afarwuah, Seth, Mridha, Malay K, Oaks, Brietta M, Matias, Susana L, Arnold, Charles D, Kumordzie, Sika M, Okronipa, Harriet, Ocansey, Maku E, and Dewey, Kathryn G

Subjects
Humans, Iron, Folic Acid, Follow-Up Studies, Child Development, Siblings, Nutritional Status, Postpartum Period, Pregnancy, Dietary Supplements, Adult, Child, Child, Preschool, Ghana, Bangladesh, Female, Male, Maternal Nutritional Physiological Phenomena, Young Adult, Child Nutritional Physiological Phenomena, child growth, nutrient supplements, preconception nutrition, Pediatric, Nutrition, Clinical Trials and Supportive Activities, Clinical Research, Reproductive health and childbirth, Zero Hunger, Nutrition and Dietetics, Nutrition & Dietetics
Abstract

Pregnancy and breastfeeding make demands on maternal nutrient stores. The extent of depletion and the degree to which nutrient stores are replenished between pregnancies has implications for a mother's nutritional status at conception of the subsequent child and therefore that child's birth outcomes and growth. Using follow-up data collected several years after a randomized effectiveness trial conducted in rural Bangladesh and a randomized efficacy trial conducted in semiurban Ghana, we evaluated the impact of maternal supplementation with small-quantity lipid-based nutrient supplements (LNS) or multiple micronutrients (MMN) through pregnancy (the index pregnancy) and 6 months postpartum on the growth status of the next living younger sibling conceived and born after the index pregnancy. In both Bangladesh (n = 472 younger siblings) and Ghana (n = 327 younger siblings), there were no overall differences in the growth status or the prevalence of undernutrition among younger siblings whose mothers had received LNS (or MMN, Ghana only) during and after the index pregnancy compared with the younger siblings of mothers who had received iron plus folic acid (IFA) during the index pregnancy (Ghana) or during and for 3 months after the index pregnancy (Bangladesh). These findings do not indicate that preconception nutrition interventions do not improve child growth. Rather, they suggest that any benefits of maternal LNS or MMN supplementation during one pregnancy and for 6 months postpartum are unlikely to extend to the growth of her next child beyond any effects due to IFA alone.

Published
2020

3. Maternal and child factors associated with child body fatness in a Ghanaian cohort

Author

Kumordzie, Sika M, Okronipa, Harriet, Arimond, Mary, Adu-Afarwuah, Seth, Ocansey, Maku E, Young, Rebecca R, Bentil, Helena J, Tamakloe, Solace M, Oaks, Brietta M, and Dewey, Kathryn G

Subjects
Biomedical and Clinical Sciences, Public Health, Health Sciences, Nutrition and Dietetics, Nutrition, Pediatric, Clinical Research, Obesity, Prevention, 2.3 Psychological, social and economic factors, Aetiology, Generic health relevance, Metabolic and endocrine, Cardiovascular, Oral and gastrointestinal, Stroke, Reproductive health and childbirth, Cancer, Adipose Tissue, Body Composition, Body Mass Index, Child Nutritional Physiological Phenomena, Child, Preschool, Cohort Studies, Diet, Dietary Supplements, Exercise, Female, Ghana, Humans, Infant, Infant, Newborn, Longitudinal Studies, Male, Mothers, Overweight, Pediatric Obesity, Snacks, Body composition, Factor analysis, Physical activity, Ghanaian children, Medical and Health Sciences, Nutrition & Dietetics, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveWe aimed to identify factors (child diet, physical activity; maternal BMI) associated with body composition of Ghanaian pre-school children.DesignLongitudinal analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD-Ghana randomized trial, which enrolled 1320 pregnant women at ≤20 weeks' gestation and followed them and their infants until 6 and 18 months postpartum, respectively. At follow-up, child age 4-6 years, we collected data on body composition (by 2H dilution), physical activity and diet, extracted dietary patterns using factor analysis, and examined the association of children's percentage body fat with maternal and child factors by regression analysis.SettingEastern Region, Ghana.ParticipantsChildren 4-6 years of age.ResultsThe analysis included 889 children with percentage body fat and dietary data at follow-up. We identified two major dietary patterns, a snacking and a cooked foods pattern. Percentage body fat was positively associated (standardized β (se)) with maternal BMI at follow-up (0·10 (0·03); P = 0·003) and negatively associated with physical activity (-0·15 (0·05); P = 0·003, unadjusted for child gender), but not associated with the snacking (0·06 (0·03); P = 0·103) or cooked foods (-0·05 (0·07); P = 0·474) pattern. Boys were more active than girls (1470 v. 1314 mean vector magnitude counts/min; P < 0·0001) and had lower percentage body fat (13·8 v. 16·9 %; P < 0·0001).ConclusionsIn this population, maternal overweight and child physical activity, especially among girls, may be key factors for addressing child overweight/obesity. We did not demonstrate a relationship between the dietary patterns and body fatness, which may be related to limitations of the dietary data available.

Published
2020

4. The effects of supplementing maternal and infant diets with lipid-based nutrient supplements on physical activity and sedentary behaviour at preschool age in Ghana

Author

Ocansey, Maku E, Pulakka, Anna, Adu-Afarwuah, Seth, Young, Rebecca R, Kumordzie, Sika M, Okronipa, Harriet, Oaks, Brietta M, Dewey, Kathryn G, and Prado, Elizabeth L

Subjects
Biomedical and Clinical Sciences, Nutrition and Dietetics, Clinical Research, Nutrition, Prevention, Pediatric, Clinical Trials and Supportive Activities, Metabolic and endocrine, Cardiovascular, Oral and gastrointestinal, Adult, Child, Preschool, Diet, Dietary Supplements, Exercise, Female, Folic Acid, Ghana, Humans, Infant, Infant Nutritional Physiological Phenomena, Infant, Newborn, Iron, Lipids, Male, Maternal Nutritional Physiological Phenomena, Micronutrients, Postpartum Period, Pregnancy, Sedentary Behavior, Lipid-based nutrient supplements, Physical activity, Accelerometers, Preschool-age children, Animal Production, Food Sciences, Nutrition & Dietetics, Animal production, Food sciences, Nutrition and dietetics
Abstract

Evidence on whether nutritional supplementation affects physical activity (PA) during early childhood is limited. We examined the long-term effects of lipid-based nutrient supplements (LNS) on total PA, moderate-to-vigorous PA (MVPA) and sedentary behaviour (SB) of children at 4-6 years using an accelerometer for 1 week. Their mothers were enrolled in the International Lipid-based Nutrient Supplement-DYAD randomised controlled trial in Ghana, assigned to daily LNS or multiple micronutrients (MMN) during pregnancy through 6 months postpartum or Fe and folic acid (IFA) during pregnancy and placebo for 6 months postpartum. From 6 to 18 months, children in the LNS group received LNS; the other two groups received no supplements. Analysis was done with intention to treat comparing two groups: LNS v. non-LNS (MMN+ IFA). Of the sub-sample of 375 children fitted with accelerometers, 353 provided sufficient data. Median vector magnitude (VM) count was 1374 (interquartile range (IQR) 309), and percentages of time in MVPA and SB were 4·8 (IQR 2) and 31 (IQR 8) %, respectively. The LNS group (n 129) had lower VM (difference in mean -73 (95 % CI -20, -126), P = 0·007) and spent more time in SB (LNS v. non-LNS: 32·3 v. 30·5 %, P = 0·020) than the non-LNS group (n 224) but did not differ in MVPA (4·4 v. 4·7 %, P = 0·198). Contrary to expectations, provision of LNS in early life slightly reduced the total PA and increased the time in SB but did not affect time in MVPA. Given reduced social-emotional difficulties in the LNS group previously reported, including hyperactivity, one possible explanation is less restless movement in the LNS group.

Published
2019

5. The association of early linear growth and haemoglobin concentration with later cognitive, motor, and social-emotional development at preschool age in Ghana.

Author

Ocansey, Maku E, Adu-Afarwuah, Seth, Kumordzie, Sika M, Okronipa, Harriet, Young, Rebecca R, Tamakloe, Solace M, Oaks, Brietta M, Arimond, Mary, Dewey, Kathryn G, and Prado, Elizabeth L

Subjects
Humans, Hemoglobins, Body Height, Follow-Up Studies, Emotions, Child Development, Mothers, Cognition, Motor Skills, Adult, Child, Child, Preschool, Ghana, Female, Male, Young Adult, Surveys and Questionnaires, cognitive development, haemoglobin concentration, linear growth, postnatal, prenatal, Nutrition & Dietetics, Nutrition and Dietetics
Abstract

It is important to identify the periods during childhood when exposure to environmental risk factors results in long-term neurodevelopmental deficits. Stunting and anaemia may be sensitive indicators of exposure to such risks. In a prospective cohort enrolled before birth, we investigated the association of developmental scores at 4-6 years with (a) birth length and linear growth during three postnatal periods and (2) haemoglobin (Hb) concentration at three time points. Children were participants in a follow-up study of a randomized controlled trial of nutritional supplementation in Ghana. At 4-6 years, cognitive, motor, and social-emotional developments were assessed using standard tests adapted for this population. We estimated the associations of length-for-age z-score (LAZ) at birth and postnatal linear growth (n = 710) and Hb (n = 617) with developmental scores in regression models, using multistage least squares analysis to calculate uncorrelated residuals for postnatal growth. Cognitive development at 4-6 years was significantly associated with LAZ at birth (β = 0.12, 95% CI = 0.05, 0.19), ΔLAZ from 6 to 18 months (β = 0.16, 95% CI = 0.04, 0.28), and Hb at 18 months (β = 0.13, 95% CI = 0.06, 0.20), but not with ΔLAZ during 0-6 months, ΔLAZ from 18 months to 4-6 years, Hb at 6 months, or Hb at 4-6 years. No evidence of associations with motor or social-emotional development were found. These results suggest that in similar contexts, the earlier periods prior to birth and up to 18 months are more sensitive to risk factors for long-term cognitive development associated with LAZ and Hb compared with later childhood. This may inform the optimal timing of interventions targeting improved cognitive development.

Published
2019

6. Maternal and Infant Lipid-Based Nutritional Supplementation Increases Height of Ghanaian Children at 4-6 Years Only if the Mother Was Not Overweight Before Conception.

Author

Kumordzie, Sika M, Adu-Afarwuah, Seth, Arimond, Mary, Young, Rebecca R, Adom, Theodosia, Boatin, Rose, Ocansey, Maku E, Okronipa, Harriet, Prado, Elizabeth L, Oaks, Brietta M, and Dewey, Kathryn G

Subjects
Adipose Tissue, Humans, Pregnancy Complications, Obesity, Growth Disorders, Lipids, Micronutrients, Body Mass Index, Body Height, Mothers, Body Composition, Pregnancy, Dietary Supplements, Adult, Child, Child, Preschool, Infant, Infant, Newborn, Ghana, Female, Prenatal Nutritional Physiological Phenomena, body composition, follow-up, growth, lipid-based nutrient supplements, prenatal supplementation, Clinical Trials and Supportive Activities, Nutrition, Pediatric, Clinical Research, Complementary and Integrative Health, Reproductive health and childbirth, Animal Production, Food Sciences, Nutrition and Dietetics, Nutrition & Dietetics
Abstract

BackgroundFew studies have evaluated the long-term effects of nutritional supplementation during the first 1000 d of life. We previously reported that maternal and child lipid-based nutrient supplements (LNS) increased child length by 18 mo.ObjectiveThe aim of this study was to examine the effects of LNS on later growth and body composition at 4-6 y of age.DesignThis was a follow-up of children in the International Lipid-based Nutrient Supplements (iLiNS)-DYAD trial in Ghana. Women (n = 1320) at ≤20 weeks of gestation were randomly assigned to: 1) iron and folic acid during pregnancy and 200 mg calcium/d for 6 mo postpartum, 2) multiple micronutrients (1-2 RDA of 18 vitamins and minerals) during both periods, or 3) maternal LNS during both periods plus child LNS from 6 to 18 mo. At 4-6 y, we compared height, height-for-age z score (HAZ), and % body fat (deuterium dilution method) between the LNS group and the 2 non-LNS groups combined.ResultsData were available for 961 children (76.5% of live births). There were no significant differences between LNS compared with non-LNS groups in height [106.7 compared with 106.3 cm (mean difference, MD, 0.36; P = 0.226)], HAZ [-0.49 compared with -0.57 (MD = 0.08; P = 0.226)], stunting (< -2 SD) [6.5 compared with 6.3% (OR = 1.00; P = 0.993)], or % body fat [15.5 compared with 15.3% (MD = 0.16; P = 0.630)]. However, there was an interaction with maternal prepregnancy BMI (kg/m2) (P-interaction = 0.046 before correction for multiple testing): among children of women with BMI

Published
2019

7. Exposure to a slightly sweet lipid-based nutrient supplement during early life does not increase the level of sweet taste most preferred among 4- to 6-year-old Ghanaian children: follow-up of a randomized controlled trial

Author

Okronipa, Harriet, Arimond, Mary, Arnold, Charles D, Young, Rebecca R, Adu-Afarwuah, Seth, Tamakloe, Solace M, Ocansey, Maku E, Kumordzie, Sika M, Oaks, Brietta M, Mennella, Julie A, and Dewey, Kathryn G

Subjects
Biomedical and Clinical Sciences, Nutrition and Dietetics, Prevention, Pediatric, Clinical Research, Nutrition, Clinical Trials and Supportive Activities, Reproductive health and childbirth, Child, Child, Preschool, Female, Follow-Up Studies, Food Preferences, Ghana, Humans, Infant, Infant Food, Lipid Metabolism, Male, Nutrients, Sucrose, Taste, lipid-based nutrient supplement, sweet taste preference, Monell forced-choice test, children, Engineering, Medical and Health Sciences, Nutrition & Dietetics, Clinical sciences, Nutrition and dietetics
Abstract

BackgroundThe impact of feeding a slightly sweet nutrient supplement early in life on later sweet taste preference is unknown.ObjectiveWe tested the hypothesis that the level of sucrose most preferred by 4-6-y-old children exposed to a slightly sweet lipid-based nutrient supplement (LNS) early in life would not be higher than that of children never exposed to LNS.DesignWe followed up children born to women (n = 1,320) who participated in a randomized trial in Ghana. In one group, LNS was provided to women on a daily basis during pregnancy and the first 6 mo postpartum and to their infants from age 6 to 18 mo (LNS group). The control groups received daily iron and folic acid or multiple micronutrients during pregnancy and the first 6 mo postpartum, with no infant supplementation (non-LNS group). At age 4-6 y, we randomly selected a subsample of children (n = 775) to assess the concentration of sucrose most preferred using the Monell 2-series, forced-choice, paired-comparison tracking procedure. We compared LNS with non-LNS group differences using a noninferiority margin of 5% weight/volume (wt/vol).ResultsOf the 624 children tested, most (61%) provided reliable responses. Among all children, the mean ± SD sucrose solution most preferred (% wt/vol) was 14.6 ± 8.6 (LNS group 14.9 ± 8.7; non-LNS group 14.2 ± 8.4). However, among children with reliable responses, it was 17.0 ± 10.2 (LNS group 17.5 ± 10.4; non-LNS group 16.5 ± 10.0). The upper level of the 95% CI of the difference between groups did not exceed the noninferiority margin in either the full sample or those with reliable responses, indicating that the LNS group did not have a higher sweet preference than the non-LNS group.ConclusionExposure to a slightly sweet nutrient supplement early in life did not increase the level of sweet taste most preferred during childhood. This trial was registered at clinicaltrials.gov as NCT00970866.

Published
2019

8. Exposure to a Slightly Sweet Lipid-Based Nutrient Supplement During Early Life Does Not Increase the Preference for or Consumption of Sweet Foods and Beverages by 4–6-y-Old Ghanaian Preschool Children: Follow-up of a Randomized Controlled Trial

Author

Okronipa, Harriet, Arimond, Mary, Young, Rebecca R, Arnold, Charles D, Adu-Afarwuah, Seth, Tamakloe, Solace M, Bentil, Helena J, Ocansey, Maku E, Kumordzie, Sika M, Oaks, Brietta M, and Dewey, Kathryn G

Subjects
Biomedical and Clinical Sciences, Nutrition and Dietetics, Nutrition, Clinical Trials and Supportive Activities, Pediatric, Clinical Research, Pediatric Research Initiative, Beverages, Child, Child, Preschool, Dietary Supplements, Female, Follow-Up Studies, Food Preferences, Ghana, Humans, Infant, Male, Maternal Nutritional Physiological Phenomena, Sweetening Agents, sweet food, sugar-sweetened beverage, preference, consumption, lipid-based nutrient supplements, children, Animal Production, Food Sciences, Nutrition & Dietetics, Animal production, Food sciences, Nutrition and dietetics
Abstract

BackgroundWhether consuming sweet foods early in life affects sweet food preferences and consumption later in childhood is unknown.ObjectiveWe tested the hypothesis that exposure to a slightly sweet lipid-based nutrient supplement (LNS) early in life would not increase preference for or consumption of sweet items at preschool age.MethodsWe followed up children who had participated in a randomized trial in Ghana in which LNS was provided to 1 group of women during pregnancy and 6 mo postpartum and to their infants from ages 6-18 mo (LNS group). The control group (non-LNS group) received iron and folic acid during pregnancy or multiple micronutrients during pregnancy and 6 mo postpartum, with no infant supplementation. At 4-6 y, we obtained data from caregivers on children's food and beverage preferences and consumption (n = 985). For a randomly selected subsample (n = 624), we assessed preference for sweet items using a photo game (range in potential scores, 0-15). For the photo game and reported consumption of sweet items, we examined group differences using predetermined noninferiority margins equivalent to an effect size of 0.2.ResultsMedian (quartile 1, quartile 3) reported consumption of sweet items (times in previous week) was 14 (8, 23) in the LNS group and 16 (9, 22) in the non-LNS group; in the photo game, the number of sweet items selected was 15 (11, 15) and 15 (11, 15), respectively. The upper level of the 95% CI of the mean difference between LNS and non-LNS groups did not exceed the noninferiority margins for these outcomes. Caregiver-reported preferences for sweet items also did not differ between groups (P = 0.9).ConclusionIn this setting, where child consumption of sweet foods was common, exposure to a slightly sweet LNS early in life did not increase preference for or consumption of sweet foods and beverages at preschool age. This trial was registered at clinicaltrials.gov as NCT00970866.

Published
2019

9. Maternal-Infant Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Affect Child Blood Pressure at 4-6 Y in Ghana: Follow-up of a Randomized Trial.

Author

Kumordzie, Sika M, Adu-Afarwuah, Seth, Young, Rebecca R, Oaks, Brietta M, Tamakloe, Solace M, Ocansey, Maku E, Okronipa, Harriet, Prado, Elizabeth L, and Dewey, Kathryn G

Subjects
Humans, Lipids, Follow-Up Studies, Blood Pressure, Dietary Supplements, Adult, Child, Child, Preschool, Infant, Ghana, Female, Young Adult, Ghanaian children, prenatal, infant nutrition, blood pressure, lipid-based nutrient supplements, supplementation, Nutrition, Cardiovascular, Clinical Research, Hypertension, Perinatal Period - Conditions Originating in Perinatal Period, Clinical Trials and Supportive Activities, Pediatric, Reproductive health and childbirth, Zero Hunger, Ghanaian children, prenatal, infant nutrition, Animal Production, Food Sciences, Nutrition and Dietetics, Nutrition & Dietetics
Abstract

BackgroundIn the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD-Ghana trial, prenatal small-quantity lipid-based nutrient supplements (LNSs) had a positive effect on birth weight. Birth weight may be inversely related to blood pressure (BP) later in life.ObjectivesWe examined the effect of the intervention on BP at 4-6 y of age, and maternal and child factors related to BP.MethodsThe iLiNS-DYAD-Ghana study was a partially double-blind, randomized controlled trial which assigned women (n = 1320) ≤20 weeks of gestation to daily supplementation with: 1) iron and folic acid during pregnancy and 200 mg Ca for 6 mo postpartum , 2) multiple micronutrients during pregnancy and postpartum, or 3) LNSs during pregnancy and postpartum plus LNSs for infants from 6 to 18 mo of age. At 4-6 y of age (n = 858, 70% of live births), we compared BP, a secondary outcome, between non-LNS and LNS groups and examined whether BP was related to several factors including maternal BP, child weight-for-age z score (WAZ), and physical activity.ResultsNon-LNS and LNS groups did not differ in systolic (99.2 ± 0.4 compared with 98.5 ± 0.6 mm Hg; P = 0.317) or diastolic (60.1 ± 0.3 compared with 60.0 ± 0.4 mm Hg; P = 0.805) BP, or prevalence of high BP (systolic or diastolic BP ≥90th percentile of the US National Heart, Lung, and Blood Institute reference: 31% compared with 28%; P = 0.251). BP at 4-6 y of age was positively related to birth weight; this relation was largely mediated through concurrent WAZ in a path model. Concurrent WAZ and maternal BP were the factors most strongly related to child BP.ConclusionsDespite greater birth weight in the LNS group, there was no intervention group difference in BP at 4-6 y. In this preschool population at high risk of adult hypertension based on BP at 4-6 y, high maternal BP and child WAZ were key factors related to BP. This trial was registered at clinicaltrials.gov as NCT00970866.

Published
2019

10. Prenatal and postnatal lipid-based nutrient supplementation and cognitive, social-emotional, and motor function in preschool-aged children in Ghana: a follow-up of a randomized controlled trial.

Author

Ocansey, Maku E, Adu-Afarwuah, Seth, Kumordzie, Sika M, Okronipa, Harriet, Young, Rebecca R, Tamakloe, Solace M, Oaks, Brietta M, Dewey, Kathryn G, and Prado, Elizabeth L

Subjects
Humans, Lipids, Micronutrients, Prenatal Care, Follow-Up Studies, Child Behavior, Emotions, Child Development, Family Characteristics, Interpersonal Relations, Cognition, Pregnancy, Dietary Supplements, Adult, Child, Child, Preschool, Infant, Ghana, Female, Male, Infant Nutritional Physiological Phenomena, Maternal Nutritional Physiological Phenomena, Young Adult, Maternal-Child Health Services, Prevention, Pediatric, Clinical Research, Behavioral and Social Science, Clinical Trials and Supportive Activities, Nutrition, Complementary and Integrative Health, Mental health, Reproductive health and childbirth, cognitive development, preschool development, lipid-based nutrient supplementation, multiple micronutrients, prenatal supplementation, postnatal supplementation, Engineering, Medical and Health Sciences, Nutrition & Dietetics
Abstract

BackgroundAdequate nutrition is necessary for brain development during pregnancy and infancy. Few randomized controlled trials of supplementation during these periods have measured later developmental outcomes.ObjectiveOur objective was to investigate the effects of provision of prenatal and postnatal lipid-based nutrient supplements (LNS) on child development at preschool age.MethodsWe conducted a follow-up study of 966 children aged 4-6 y in 2016, born to women who participated in the International Lipid-Based Nutrient Supplements-DYAD trial conducted in Ghana in 2009-2014, representing 79% of eligible children. Women ≤20 weeks of gestation were randomized to daily LNS or multiple micronutrient (MMN) capsules during pregnancy through 6 mo postpartum or iron and folic acid (IFA) capsules during pregnancy and calcium placebo capsules during 6 mo postpartum. Children in the LNS group received LNS from 6 to 18 mo. Primary outcomes of this follow-up study were (1) a cognitive factor score based on a test battery adapted from several standard tests, 2) fine motor score (9-hole pegboard test), and (3) social-emotional difficulties (Strengths and Difficulties Questionnaire; SDQ). Eight secondary outcomes were calculated in specific domains (e.g., language, SDQ prosocial). Analysis was by a complete case intention to treat in a 2-group comparison: LNS compared with non-LNS (MMN + IFA).ResultsChildren in the LNS group had significantly lower social-emotional difficulties z-scores than children in the non-LNS group (adjusted for child age β = -0.12, 95% CI: -0.25, 0.02, P = 0.087; fully adjusted β = -0.16, 95% CI: -0.29, -0.03, P = 0.013). The effect of LNS on social-emotional difficulties score was larger among children living in households with lower home environment scores (P-interaction = 0.081). No other outcomes differed between the 2 intervention groups.ConclusionsProvision of LNS during the first 1000 d of development improved behavioral function, particularly for children from low nurturing and stimulation households, but did not affect cognition at preschool age in this setting. Trial Registration: clinicaltrials.gov, Identifier NCT00970866.

Published
2019

11. Evaluation of a tablet‐based assessment tool for measuring cognition among children 4–6 years of age in Ghana

Author

Haiying Yuan, Maku Ocansey, Seth Adu‐Afarwuah, Margaret Sheridan, Amar Hamoudi, Harriet Okronipa, Sika M. Kumordzie, Brietta M. Oaks, and Elizabeth Prado

Subjects
Pediatric, Psychometrics, cognition assessment, Neurosciences, Ghana, Inhibition, Psychological, Behavioral Neuroscience, Child Development, Cognition, Clinical Research, Child, Preschool, Behavioral and Social Science, tablet tasks, Humans, Psychological, Psychology, Mental health, Cognitive Sciences, low- and middle-income countries, Child, Preschool, Inhibition
Abstract

ObjectivesTo investigate several basic psychometric properties, including construct, convergent and discriminant validity, of the tablet-based Rapid Assessment of Cognitive and Emotional Regulation (RACER) among children aged 4-6 years in Ghana.MethodsWe investigated whether RACER tasks administered to children in Ghana could successfully reproduce expected patterns of performance previously found in high-income countries on similar tasks assessing inhibitory control (e.g., slower responses on inhibition trials), declarative memory (e.g., higher accuracy on previously seen items), and procedural memory (e.g., faster responses on sequence blocks). Next, we assessed the validity of declarative memory and inhibitory control scores by examining associations of these scores with corresponding paper-based test scores and increasing child age. Lastly, we examined whether RACER was more sensitive than paper-based tests to environmental risk factors common in low- and middle-income countries (LMICs).ResultsOf the 966 children enrolled, more than 96% completed the declarative memory and inhibitory control tasks; however, around 30% of children were excluded from data analysis on the procedural memory task due to missing more than half of trials. The performance of children in Ghana replicated previously documented patterns of performance. RACER inhibitory control accuracy score was significantly correlated with child age (r (929)=.09, p =.007). However, our findings did not support other hypotheses.ConclusionsThe high task completion rates and replication of expected patterns support that certain RACER sub-tasks are feasible for measuring child cognitive development in LMIC settings. However, this study did not provide evidence to support that RACER is a valid tool to capture meaningful individual differences among children aged 4-6 years in Ghana.

Published
2022

12. Impact of a nutritional supplement during gestation and early childhood on child salivary cortisol, hair cortisol, and telomere length at 4–6 years of age: a follow-up of a randomized controlled trial

Author

Sika M Kumordzie, Seth Adu-Afarwuah, Maku E. Ocansey, Jue Lin, Dana L. Smith, Mark L. Laudenslager, Brietta M Oaks, Rebecca R Young, Charles D Arnold, Kathryn G. Dewey, Helena J Bentil, and Harriet Okronipa

Subjects
Hydrocortisone, Physiology, Reproductive health and childbirth, Ghana, Cortisol, law.invention, Behavioral Neuroscience, 0302 clinical medicine, Original Research Reports, Randomized controlled trial, Pregnancy, law, telomere length, Medicine, Chronic stress, Micronutrients, Early childhood, Pediatric, child, Telomere, Micronutrient, Psychiatry and Mental health, Mental Health, nutrition, Neuropsychology and Physiological Psychology, Child, Preschool, Gestation, Zero Hunger, Female, pregnancy, Adolescent, Nutritional Supplementation, Clinical Trials and Supportive Activities, Clinical Sciences, Stress, Basic Behavioral and Social Science, 03 medical and health sciences, Clinical Research, Complementary and Integrative Health, Behavioral and Social Science, Humans, Preschool, Neurology & Neurosurgery, Endocrine and Autonomic Systems, business.industry, Prevention, Stressor, Infant, medicine.disease, 030227 psychiatry, Dietary Supplements, Psychological, Generic health relevance, business, Stress, Psychological, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

Dysregulation of the stress response can occur early in life and may be affected by nutrition. Our objective was to evaluate the long-term effect of nutritional supplementation during gestation and early childhood on child cortisol and buccal telomere length (a marker of cellular aging) at 4-6years of age. We conducted a follow-up study of children born to women who participated in a nutritional supplementation trial in Ghana. In one group, a lipid-based nutrient supplement (LNS) was provided to women during gestation and the first 6months postpartum and to their infants from age 6 to 18months. The control groups received either iron and folic acid (IFA) during gestation or multiple micronutrients during gestation and the first 6months postpartum, with no infant supplementation. At age 4-6years, we measured hair cortisol, buccal telomere length, and salivary cortisol before and after a stressor. Salivary cortisol was available for 364 children across all three trial arms and hair cortisol and telomere length were available for a subset of children (n = 275 and 278, respectively) from the LNS and IFA groups. Telomere length, salivary cortisol, and hair cortisol did not differ by supplementation group. Overall, these findings suggest that nutritional supplementation given during gestation and early childhood does not have an effect on child stress response or chronic stress in children at 4-6years. Trial registration: ClinicalTrials.gov Identifier NCT00970866.Lay SummaryThis study addressed a research gap about whether improved nutrition during pregnancy and early childhood impacts telomere length and cortisol in preschool children. There was no difference in child telomere length or cortisol between two trial arms of a nutritional supplementation trial that began during pregnancy. The research outcomes indicate lipid-based nutrient supplements, a relatively new form of supplementation, do not have an effect on markers of stress or cellular aging measured in later childhood.

Published
2020

13. Maternal and child factors associated with child body fatness in a Ghanaian cohort

Author

Seth Adu-Afarwuah, Maku E. Ocansey, Sika M Kumordzie, Kathryn G. Dewey, Solace M Tamakloe, Helena Bentil, Harriet Okronipa, Mary Arimond, Brietta M Oaks, and Rebecca R Young

Subjects
Male, Pediatric Obesity, Medicine (miscellaneous), Ghana, Body composition, Medical and Health Sciences, law.invention, Body Mass Index, Cohort Studies, Randomized controlled trial, law, Medicine, Nutritional Epidemiology, Longitudinal Studies, Child, education.field_of_study, Nutrition and Dietetics, Snacking, Adipose Tissue, Child, Preschool, Cohort, Gestation, Female, Factor analysis, Child Nutritional Physiological Phenomena, Research Paper, Population, Physical activity, Mothers, Humans, education, Preschool, Exercise, Nutrition & Dietetics, business.industry, Public Health, Environmental and Occupational Health, Body fatness, Infant, Newborn, Infant, Overweight, medicine.disease, Newborn, Obesity, Diet, Dietary Supplements, Snacks, business, Ghanaian children, Demography
Abstract

Objective:We aimed to identify factors (child diet, physical activity; maternal BMI) associated with body composition of Ghanaian pre-school children.Design:Longitudinal analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD-Ghana randomized trial, which enrolled 1320 pregnant women at ≤20 weeks’ gestation and followed them and their infants until 6 and 18 months postpartum, respectively. At follow-up, child age 4–6 years, we collected data on body composition (by2H dilution), physical activity and diet, extracted dietary patterns using factor analysis, and examined the association of children’s percentage body fat with maternal and child factors by regression analysis.Setting:Eastern Region, Ghana.Participants:Children 4–6 years of age.Results:The analysis included 889 children with percentage body fat and dietary data at follow-up. We identified two major dietary patterns, a snacking and a cooked foods pattern. Percentage body fat was positively associated (standardizedβ(se)) with maternal BMI at follow-up (0·10 (0·03);P= 0·003) and negatively associated with physical activity (−0·15 (0·05);P= 0·003, unadjusted for child gender), but not associated with the snacking (0·06 (0·03);P= 0·103) or cooked foods (−0·05 (0·07);P= 0·474) pattern. Boys were more active than girls (1470v.1314 mean vector magnitude counts/min;P< 0·0001) and had lower percentage body fat (13·8v.16·9 %;P< 0·0001).Conclusions:In this population, maternal overweight and child physical activity, especially among girls, may be key factors for addressing child overweight/obesity. We did not demonstrate a relationship between the dietary patterns and body fatness, which may be related to limitations of the dietary data available.

Published
2020

14. The impact of maternal supplementation during pregnancy and the first 6 months postpartum on the growth status of the next child born after the intervention period: Follow‐up results from Bangladesh and Ghana

Author

Malay K Mridha, Katherine P. Adams, Kathryn G. Dewey, Harriet Okronipa, Sika M Kumordzie, Susana L Matias, Seth Adu-Afarwuah, Maku E. Ocansey, Charles D Arnold, and Brietta M Oaks

Subjects
0301 basic medicine, Male, Breastfeeding, Follow up results, Reproductive health and childbirth, Ghana, 0302 clinical medicine, Child Development, Pregnancy, 030212 general & internal medicine, Child growth, Child, Pediatric, Bangladesh, Nutrition and Dietetics, Postpartum Period, Obstetrics and Gynecology, Micronutrient, child growth, Child, Preschool, Zero Hunger, Original Article, Female, Child Nutritional Physiological Phenomena, Adult, Iron, Clinical Trials and Supportive Activities, Nutritional Status, 03 medical and health sciences, Young Adult, preconception nutrition, Folic Acid, Clinical Research, Intervention (counseling), medicine, Humans, Younger sibling, Preschool, nutrient supplements, Nutrition, 030109 nutrition & dietetics, Nutrition & Dietetics, business.industry, Siblings, Public Health, Environmental and Occupational Health, Original Articles, Maternal Nutritional Physiological Phenomena, medicine.disease, Malnutrition, Pediatrics, Perinatology and Child Health, Dietary Supplements, business, Demography, Follow-Up Studies
Abstract

Pregnancy and breastfeeding make demands on maternal nutrient stores. The extent of depletion and the degree to which nutrient stores are replenished between pregnancies has implications for a mother's nutritional status at conception of the subsequent child and therefore that child's birth outcomes and growth. Using follow‐up data collected several years after a randomized effectiveness trial conducted in rural Bangladesh and a randomized efficacy trial conducted in semiurban Ghana, we evaluated the impact of maternal supplementation with small‐quantity lipid‐based nutrient supplements (LNS) or multiple micronutrients (MMN) through pregnancy (the index pregnancy) and 6 months postpartum on the growth status of the next living younger sibling conceived and born after the index pregnancy. In both Bangladesh (n = 472 younger siblings) and Ghana (n = 327 younger siblings), there were no overall differences in the growth status or the prevalence of undernutrition among younger siblings whose mothers had received LNS (or MMN, Ghana only) during and after the index pregnancy compared with the younger siblings of mothers who had received iron plus folic acid (IFA) during the index pregnancy (Ghana) or during and for 3 months after the index pregnancy (Bangladesh). These findings do not indicate that preconception nutrition interventions do not improve child growth. Rather, they suggest that any benefits of maternal LNS or MMN supplementation during one pregnancy and for 6 months postpartum are unlikely to extend to the growth of her next child beyond any effects due to IFA alone.

Published
2020

15. The effects of supplementing maternal and infant diets with lipid-based nutrient supplements on physical activity and sedentary behaviour at preschool age in Ghana

Author

Harriet Okronipa, Sika M Kumordzie, Anna Pulakka, Seth Adu-Afarwuah, Brietta M Oaks, Rebecca R Young, Maku E. Ocansey, Kathryn G. Dewey, and Elizabeth L. Prado

Subjects
Male, Medicine (miscellaneous), Ghana, law.invention, 0302 clinical medicine, Nutrient, Randomized controlled trial, law, Interquartile range, Pregnancy, Medicine, 030212 general & internal medicine, Micronutrients, Child, Infant Nutritional Physiological Phenomena, Lipid-based nutrient supplements, Nutrition and Dietetics, integumentary system, Postpartum Period, Articles, Micronutrient, Lipids, Child, Preschool, Female, tissues, Adult, medicine.medical_specialty, Nutritional Supplementation, Iron, Placebo, 03 medical and health sciences, Preschool-age children, Food Sciences, Folic Acid, Animal Production, Internal medicine, Humans, Preschool, Exercise, Intention-to-treat analysis, Nutrition & Dietetics, business.industry, Physical activity, Infant, Newborn, Infant, 030229 sport sciences, Maternal Nutritional Physiological Phenomena, medicine.disease, Newborn, Diet, Dietary Supplements, Sedentary Behavior, Accelerometers, business
Abstract

Evidence on whether nutritional supplementation affects physical activity (PA) during early childhood is limited. We examined the long-term effects of lipid-based nutrient supplements (LNS) on total PA, moderate-to-vigorous PA (MVPA) and sedentary behaviour (SB) of children at 4–6 years using an accelerometer for 1 week. Their mothers were enrolled in the International Lipid-based Nutrient Supplement-DYAD randomised controlled trial in Ghana, assigned to daily LNS or multiple micronutrients (MMN) during pregnancy through 6 months postpartum or Fe and folic acid (IFA) during pregnancy and placebo for 6 months postpartum. From 6 to 18 months, children in the LNS group received LNS; the other two groups received no supplements. Analysis was done with intention to treat comparing two groups: LNSv. non-LNS (MMN+ IFA). Of the sub-sample of 375 children fitted with accelerometers, 353 provided sufficient data. Median vector magnitude (VM) count was 1374 (interquartile range (IQR) 309), and percentages of time in MVPA and SB were 4·8 (IQR 2) and 31 (IQR 8) %, respectively. The LNS group (n129) had lower VM (difference in mean −73 (95 % CI −20, −126),P= 0·007) and spent more time in SB (LNSv. non-LNS: 32·3v. 30·5 %,P= 0·020) than the non-LNS group (n224) but did not differ in MVPA (4·4v. 4·7 %,P= 0·198). Contrary to expectations, provision of LNS in early life slightly reduced the total PA and increased the time in SB but did not affect time in MVPA. Given reduced social-emotional difficulties in the LNS group previously reported, including hyperactivity, one possible explanation is less restless movement in the LNS group.

Published
2019

16. The Association of Early Linear Growth and Hemoglobin Concentration with Later Cognitive, Motor and Social-emotional Development at Preschool Age in Ghana

Author

Kathryn G. Dewey, Seth Adu-Afarwuah, Mary Arimond, Solace M Tamakloe, Brietta M Oaks, Maku E. Ocansey, Rebecca R Young, Sika M Kumordzie, Harriet Okronipa, and Elizabeth L. Prado

Subjects
Male, haemoglobin concentration, 0301 basic medicine, Emotions, Psychological intervention, Ghana, law.invention, Hemoglobins, Child Development, Cognition, 0302 clinical medicine, Randomized controlled trial, law, Surveys and Questionnaires, Cognitive development, Medicine, Prenatal, 030212 general & internal medicine, Child, Prospective cohort study, linear growth, education.field_of_study, postnatal, Nutrition and Dietetics, Obstetrics and Gynecology, Regression analysis, Motor Skills, Child, Preschool, Original Article, Female, cognitive development, Adult, prenatal, Nutritional Supplementation, Population, Mothers, hemoglobin concentration, Young Adult, 03 medical and health sciences, Humans, Preschool, education, 030109 nutrition & dietetics, Nutrition & Dietetics, business.industry, Public Health, Environmental and Occupational Health, Original Articles, Body Height, Pediatrics, Perinatology and Child Health, business, Follow-Up Studies, Demography
Abstract

It is important to identify the periods during childhood when exposure to environmental risk factors results in long-term neurodevelopmental deficits. Stunting and anaemia may be sensitive indicators of exposure to such risks. In a prospective cohort enrolled before birth, we investigated the association of developmental scores at 4-6years with (a) birth length and linear growth during three postnatal periods and (2) haemoglobin (Hb) concentration at three time points. Children were participants in a follow-up study of a randomized controlled trial of nutritional supplementation in Ghana. At 4-6years, cognitive, motor, and social-emotional developments were assessed using standard tests adapted for this population. We estimated the associations of length-for-age z-score (LAZ) at birth and postnatal linear growth (n=710) and Hb (n=617) with developmental scores in regression models, using multistage least squares analysis to calculate uncorrelated residuals for postnatal growth. Cognitive development at 4-6years was significantly associated with LAZ at birth (β=0.12, 95% CI=0.05, 0.19), ΔLAZ from 6 to 18months (β=0.16, 95% CI=0.04, 0.28), and Hb at 18months (β=0.13, 95% CI=0.06, 0.20), but not with ΔLAZ during 0-6months, ΔLAZ from 18months to 4-6years, Hb at 6months, or Hb at 4-6years. No evidence of associations with motor or social-emotional development were found. These results suggest that in similar contexts, the earlier periods prior to birth and up to 18months are more sensitive to risk factors for long-term cognitive development associated with LAZ and Hb compared with later childhood. This may inform the optimal timing of interventions targeting improved cognitive development.

Published
2019

17. Exposure to a slightly sweet lipid-based nutrient supplement during early life does not increase the level of sweet taste most preferred among 4- to 6-year-old Ghanaian children: follow-up of a randomized controlled trial

Author

Harriet, Okronipa, Mary, Arimond, Charles D, Arnold, Rebecca R, Young, Seth, Adu-Afarwuah, Solace M, Tamakloe, Maku E, Ocansey, Sika M, Kumordzie, Brietta M, Oaks, Julie A, Mennella, and Kathryn G, Dewey

Subjects
Male, Sucrose, integumentary system, Infant, Nutrients, Lipid Metabolism, Ghana, sweet taste preference, Food Preferences, Original Research Communications, children, Child, Preschool, Taste, Monell forced-choice test, Humans, Female, Infant Food, Child, lipid-based nutrient supplement, Follow-Up Studies
Abstract

Background The impact of feeding a slightly sweet nutrient supplement early in life on later sweet taste preference is unknown. Objective We tested the hypothesis that the level of sucrose most preferred by 4–6-y-old children exposed to a slightly sweet lipid-based nutrient supplement (LNS) early in life would not be higher than that of children never exposed to LNS. Design We followed up children born to women (n = 1,320) who participated in a randomized trial in Ghana. In one group, LNS was provided to women on a daily basis during pregnancy and the first 6 mo postpartum and to their infants from age 6 to 18 mo (LNS group). The control groups received daily iron and folic acid or multiple micronutrients during pregnancy and the first 6 mo postpartum, with no infant supplementation (non-LNS group). At age 4–6 y, we randomly selected a subsample of children (n = 775) to assess the concentration of sucrose most preferred using the Monell 2-series, forced-choice, paired-comparison tracking procedure. We compared LNS with non-LNS group differences using a noninferiority margin of 5% weight/volume (wt/vol). Results Of the 624 children tested, most (61%) provided reliable responses. Among all children, the mean ± SD sucrose solution most preferred (% wt/vol) was 14.6 ± 8.6 (LNS group 14.9 ± 8.7; non-LNS group 14.2 ± 8.4). However, among children with reliable responses, it was 17.0 ± 10.2 (LNS group 17.5 ± 10.4; non-LNS group 16.5 ± 10.0). The upper level of the 95% CI of the difference between groups did not exceed the noninferiority margin in either the full sample or those with reliable responses, indicating that the LNS group did not have a higher sweet preference than the non-LNS group. Conclusion Exposure to a slightly sweet nutrient supplement early in life did not increase the level of sweet taste most preferred during childhood. This trial was registered at clinicaltrials.gov as NCT00970866.

Published
2018

18. Prenatal and postnatal lipid-based nutrient supplementation and cognitive, social-emotional, and motor function in preschool-aged children in Ghana: a follow-up of a randomized controlled trial

Author

Seth Adu-Afarwuah, Maku E. Ocansey, Harriet Okronipa, Solace M Tamakloe, Brietta M Oaks, Rebecca R Young, Elizabeth L. Prado, Sika M Kumordzie, and Kathryn G Dewey

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, prenatal supplementation, Maternal-Child Health Services, Emotions, multiple micronutrients, Medicine (miscellaneous), Child Behavior, Prenatal care, Ghana, postnatal supplementation, law.invention, Young Adult, Child Development, Cognition, Randomized controlled trial, law, Pregnancy, Medicine, Humans, Interpersonal Relations, Micronutrients, Young adult, Child, Infant Nutritional Physiological Phenomena, Family Characteristics, Nutrition and Dietetics, Intention-to-treat analysis, business.industry, Infant, lipid-based nutrient supplementation, Prenatal Care, Strengths and Difficulties Questionnaire, Maternal Nutritional Physiological Phenomena, medicine.disease, Child development, Lipids, preschool development, Original Research Communications, Child, Preschool, Dietary Supplements, Female, business, Postpartum period, Follow-Up Studies, cognitive development
Abstract

Author(s): Ocansey, Maku E; Adu-Afarwuah, Seth; Kumordzie, Sika M; Okronipa, Harriet; Young, Rebecca R; Tamakloe, Solace M; Oaks, Brietta M; Dewey, Kathryn G; Prado, Elizabeth L | Abstract: Background:Adequate nutrition is necessary for brain development during pregnancy and infancy. Few randomized controlled trials of supplementation during these periods have measured later developmental outcomes. Objective:Our objective was to investigate the effects of provision of prenatal and postnatal lipid-based nutrient supplements (LNS) on child development at preschool age. Methods:We conducted a follow-up study of 966 children aged 4-6 y in 2016, born to women who participated in the International Lipid-Based Nutrient Supplements-DYAD trial conducted in Ghana in 2009-2014, representing 79% of eligible children. Women ≤20 weeks of gestation were randomized to daily LNS or multiple micronutrient (MMN) capsules during pregnancy through 6 mo postpartum or iron and folic acid (IFA) capsules during pregnancy and calcium placebo capsules during 6 mo postpartum. Children in the LNS group received LNS from 6 to 18 mo. Primary outcomes of this follow-up study were (1) a cognitive factor score based on a test battery adapted from several standard tests, 2) fine motor score (9-hole pegboard test), and (3) social-emotional difficulties (Strengths and Difficulties Questionnaire; SDQ). Eight secondary outcomes were calculated in specific domains (e.g., language, SDQ prosocial). Analysis was by a complete case intention to treat in a 2-group comparison: LNS compared with non-LNS (MMNn+nIFA). Results:Children in the LNS group had significantly lower social-emotional difficulties z-scores than children in the non-LNS group (adjusted for child age βn=n-0.12, 95% CI: -0.25, 0.02, Pn=n0.087; fully adjusted βn=n-0.16, 95% CI: -0.29, -0.03, Pn=n0.013). The effect of LNS on social-emotional difficulties score was larger among children living in households with lower home environment scores (P-interactionn=n0.081). No other outcomes differed between the 2 intervention groups. Conclusions:Provision of LNS during the first 1000 d of development improved behavioral function, particularly for children from low nurturing and stimulation households, but did not affect cognition at preschool age in this setting. Trial Registration: clinicaltrials.gov, Identifier NCT00970866.

Published
2018

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