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Summary Background Supplementation of vitamin A in children aged 6–59 months improves child survival and is implemented as global policy. Studies of the efficacy of supplementation of infants in the neonatal period have inconsistent results. We aimed to assess the efficacy of oral supplementation with vitamin A given to infants in the first 3 days of life to reduce mortality between supplementation and 180 days (6 months). Methods We did an individually randomised, double-blind, placebo-controlled trial of infants born in the Morogoro and Dar es Salaam regions of Tanzania. Women were identified during antenatal clinic visits or in the labour wards of public health facilities in Dar es Salaam. In Kilombero, Ulanga, and Kilosa districts, women were seen at home as part of the health and demographic surveillance system. Newborn infants were eligible for randomisation if they were able to feed orally and if the family intended to stay in the study area for at least 6 months. We randomly assigned infants to receive one dose of 50 000 IU of vitamin A or placebo in the first 3 days after birth. Infants were randomly assigned in blocks of 20, and investigators, participants’ families, and data analysis teams were masked to treatment assignment. We assessed infants on day 1 and day 3 after dosing, as well as at 1, 3, 6, and 12 months after birth. The primary endpoint was mortality at 6 months, assessed by field interviews. The primary analysis included only children who were not lost to follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12610000636055. Findings Between Aug 26, 2010, and March 3, 2013, 31 999 newborn babies were randomly assigned to receive vitamin A (n=15 995) or placebo (n=16 004; 15 428 and 15 464 included in analysis of mortality at 6 months, respectively). We did not find any evidence for a beneficial effect of vitamin A supplementation on mortality in infants at 6 months (26 deaths per 1000 livebirths in vitamin A vs 24 deaths per 1000 livebirths in placebo group; risk ratio 1·10, 95% CI 0·95–1·26; p=0·193). There was no evidence of a differential effect for vitamin A supplementation on mortality by sex; risk ratio for mortality at 6 months for boys was 1·08 (0·90–1·29) and for girls was 1·12 (0·91–1·39). There was also no evidence of adverse effects of supplementation within 3 days of dosing. Interpretation Neonatal vitamin A supplementation did not result in any immediate adverse events, but had no beneficial effect on survival in infants in Tanzania. These results strengthen the evidence against a global policy recommendation for neonatal vitamin A supplementation.

BackgroundVitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo.Methods/DesignThe trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrolment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation.DiscussionThe three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies.Trial RegistrationGhana: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12610000582055; India: CLINICALTRIALS.GOV - NCT01138449; Tanzania: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12610000636055.

OBJECTIVETo describe the burden of dysglycemia—abnormal glucose metabolism indicative of diabetes or high risk for diabetes—among U.S. women of childbearing age, focusing on differences by race/ethnicity.RESEARCH DESIGN AND METHODSUsing U.S. National Health and Nutrition Examination Survey data (1999–2008), we calculated the burden of dysglycemia (i.e., prediabetes or diabetes from measures of fasting glucose, A1C, and self-report) in nonpregnant women of childbearing age (15–49 years) by race/ethnicity status. We estimated prevalence risk ratios (PRRs) for dysglycemia in subpopulations stratified by BMI (measured as kilograms divided by the square of height in meters), using predicted marginal estimates and adjusting for age, waist circumference, C-reactive protein, and socioeconomic factors.RESULTSBased on data from 7,162 nonpregnant women, representing >59,000,000 women nationwide, 19% (95% CI 17.2–20.9) had some level of dysglycemia, with higher crude prevalence among non-Hispanic blacks and Mexican Americans vs. non-Hispanic whites (26.3% [95% CI 22.3–30.8] and 23.8% [19.5–28.7] vs. 16.8% [14.4–19.6], respectively). In women with BMI <25 kg/m2, dysglycemia prevalence was roughly twice as high in both non-Hispanic blacks and Mexican Americans vs. non-Hispanic whites. This relative increase persisted in adjusted models (PRRadj 1.86 [1.16–2.98] and 2.23 [1.38–3.60] for non-Hispanic blacks and Mexican Americans, respectively). For women with BMI 25–29.99 kg/m2, only non-Hispanic blacks showed increased prevalence vs. non-Hispanic whites (PRRadj 1.55 [1.03–2.34] and 1.28 [0.73–2.26] for non-Hispanic blacks and Mexican Americans, respectively). In women with BMI >30 kg/m2, there was no significant increase in prevalence of dysglycemia by race/ethnicity category.CONCLUSIONSOur findings show that dysglycemia affects a significant portion of U.S. women of childbearing age and that disparities by race/ethnicity are most prominent in the nonoverweight/nonobese.