Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Apr 4;385(9975):1324-32.
doi: 10.1016/S0140-6736(14)61731-1. Epub 2014 Dec 11.

Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial

Honorati Masanja  1 , Emily R Smith  2 , Alfa Muhihi  3 , Christina Briegleb  2 , Salum Mshamu  3 , Julia Ruben  2 , Ramadhani Abdallah Noor  4 , Polyna Khudyakov  2 , Sachiyo Yoshida  5 , Jose Martines  5 , Rajiv Bahl  5 , Wafaie W Fawzi  2 ; Neovita Tanzania Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial

Honorati Masanja et al. Lancet. .

Abstract

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.

Funding: Bill & Melinda Gates Foundation to WHO.

PubMed Disclaimer

Conflict of interest statement

Declaration of interests

We declare no competing interests.

Figures

Figure 1
Figure 1
Trial profile
Figure 2
Figure 2
Kaplan-Meier survival curve up to 12 months
See this image and copyright information in PMC

Comment in

References

    1. UNICEF, WHO, The World Bank, UN. Levels & Trends in Child Mortality: Estimates Developed by the UN Inter-agency Group for Child Mortality Estimation. New York: United Nations Children’s Fund; 2013.
    1. Oestergaard MZ, Inoue M, Yoshida S, 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;8:e1001080. - PMC - PubMed
    1. Bhutta ZA, Ahmed T, Black RE, et al. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008;371:417–40. - PubMed
    1. WHO. A global agenda for combating malnutrition. Geneva: World Health Organization; 2000. Nutrition for Health and Development.
    1. WHO. WHO global database on vitamin A deficiency. Geneva: World Health Organization; 2009. Global prevalence of vitamin A deficiency in populations at risk 1995–2005.

Publication types

MeSH terms