ArticlesEffect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial
Introduction
Every year, an estimated 6·9 million children die before their fifth birthday. About 44% of deaths of children younger than 5 years occur in the neonatal period, mostly in southeast Asia and sub-Saharan Africa.1 The Millennium Development Goal for child survival will not be achieved without additional investments to address newborn baby deaths. Interest to estimate trends and causes of newborn deaths2 and to reduce mortality with safe and efficacious interventions3 has increased. Vitamin A deficiency is thought to be a major public health issue in low-income countries.4, 5 Evidence from a systematic review6 and meta-analyses7, 8 of randomised controlled trials indicate a significant benefit of periodic vitamin A supplementation for children aged 6–59 months, reducing all-cause mortality by 23–30%. This body of evidence prompted policy recommendations by WHO9 and catalysed the implementation of large-scale supplementation programmes for children younger than 5 years to improve child survival.9
Results from studies to establish whether vitamin A supplementation can provide similar benefits in children younger than 6 months have conflicting results, ranging from no benefit10 to potential benefit11, 12, 13 or possible harm, at least in subsets of children.14, 15 This conflicting evidence prompted the development of large trials to generate the necessary evidence to inform global programmes that aim to improve child survival.16
We did a trial in Tanzania to establish the effect on infant mortality of vitamin A supplementation given on the day of birth or within the next 2 days. This is one of three large trials recommended by a technical consultation team convened by WHO in December, 2008, to inform global policy for or against newborn vitamin A supplementation. Two companion studies done in India and Ghana are reported elsewhere.17, 18
Section snippets
Study design and participants
We did a randomised double-blind, placebo-controlled trial in Dar es Salaam and Morogoro regions of Tanzania. The characteristics of the study areas have been described elsewhere.16 In Dar es Salaam, we enrolled mothers and newborn babies from ten large antenatal clinics and labour wards in the catchment areas, and in the Morogoro region, the study was nested within the Ifakara Health Institute's health and demographic surveillance system (HDSS). The Ifakara HDSS covers about 2400 km2 and is
Results
Between Aug 26, 2010, and March 3, 2013, we identified and assessed 34 133 livebirths for eligibility (figure 1). 1290 were not screened because they did not consent, died before screening, or could not be contacted. 844 (3%) newborn infants were excluded (figure 1). We randomly assigned 31 999 newborn babies to receive either vitamin A (n=15 995) or placebo (n=16 004). Most (24 888; 78%) infants received vitamin A or placebo within 24 h (table 1). Maternal and infant characteristics were
Discussion
Provision of one dose of vitamin A at birth was thought to be a low-cost intervention that could have significant protective effects on development of the immune system and early infant mortality.23 In this trial we did not show a beneficial effect on survival at age 6 months in infants given vitamin A supplementation within the first 3 days after birth, although the findings do not exclude the possibility of a slight increased risk of death.
Our results are consistent with a companion trial in
References (28)
- et al.
What works? Interventions for maternal and child undernutrition and survival
Lancet
(2008) - et al.
Mortality of infants <6 mo of age supplemented with vitamin A: a randomized, double-masked trial in Nepal
Am J Clin Nutr
(1995) - et al.
Impact of neonatal vitamin A supplementation on infant morbidity and mortality
J Pediatr
(1996) - et al.
Effect of postpartum maternal or neonatal vitamin A supplementation on infant mortality among infants born to HIV-negative mothers in Zimbabwe
Am J Clin Nutr
(2005) - et al.
Neonatal vitamin A supplementation and infant survival
Lancet
(2010) - et al.
Child survival gains in Tanzania: analysis of data from demographic and health surveys
Lancet
(2008) Levels & Trends in Child Mortality: Estimates Developed by the UN Inter-agency Group for Child Mortality Estimation
(2013)- et al.
Neonatal mortality levels for 193 countries in 2009 with trends since 1990: a systematic analysis of progress, projections, and priorities
PLoS Med
(2011) Nutrition for Health and Development. A global agenda for combating malnutrition
(2000)Global prevalence of vitamin A deficiency in populations at risk 1995–2005. WHO global database on vitamin A deficiency
(2009)
Vitamin A supplementation for preventing morbidity and mortality in children from 6 months to 5 years of age
Cochrane Database Syst Rev
Vitamin A supplementation and child mortality. A meta-analysis
JAMA
Vitamin A supplementation in infectious diseases: a meta-analysis
BMJ
Vitamin A supplements. A guide to their use in the treatment and prevention of vitamin A deficiency and xerophthalmia
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