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
. 2008 Jun 21;336(7658):1416-20.
doi: 10.1136/bmj.39542.509444.AE. Epub 2008 Jun 16.

Effect of 50,000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial

Christine Stabell Benn  1 , Birgitte Rode Diness, Adam Roth, Ernesto Nante, Ane Baerent Fisker, Ida Maria Lisse, Maria Yazdanbakhsh, Hilton Whittle, Amabelia Rodrigues, Peter Aaby
Affiliations
Randomized Controlled Trial

Effect of 50,000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial

Christine Stabell Benn et al. BMJ. .

Abstract

Objective: To investigate the effect of high dose vitamin A supplementation given with BCG vaccine at birth in an African setting with high infant mortality.

Design: Randomised placebo controlled trial. Setting Bandim Health Project's demographic surveillance system in Guinea-Bissau, covering approximately 90,000 inhabitants. Participants 4345 infants due to receive BCG.

Intervention: Infants were randomised to 50,000 IU vitamin A or placebo and followed until age 12 months.

Main outcome measure: Mortality rate ratios.

Results: 174 children died during follow-up (mortality=47/1000 person-years). Vitamin A supplementation was not significantly associated with mortality; the mortality rate ratio was 1.07 (95% confidence interval 0.79 to 1.44). The effect was 1.00 (0.65 to 1.56) during the first four months and 1.13 (0.75 to 1.68) from 4 to 12 months of age. The mortality rate ratio in boys was 0.84 (0.55 to 1.27) compared with 1.39 (0.90 to 2.14) in girls (P for interaction=0.10). An explorative analysis revealed a strong interaction between vitamin A and season of administration.

Conclusions: Vitamin A supplementation given with BCG vaccine at birth had no significant benefit in this African setting. Although little doubt exists that vitamin A supplementation reduces mortality in older children, a global recommendation of supplementation for all newborn infants may not contribute to better survival.

Trial registration: Clinical trials NCT00168597.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

None
Fig 1 Trial profile. VAS=vitamin A supplementation
None
Fig 2 Kaplan-Meier estimates of death in vitamin A and placebo recipients
None
Fig 3 Kaplan-Meier estimates of death in vitamin A and placebo recipients by sex
See this image and copyright information in PMC

Comment in

References

    1. Fawzi WW, Chalmers TC, Herrera MG, Mosteller F. Vitamin A supplementation and child mortality: a meta-analysis. JAMA 1993;269:898-903. - PubMed
    1. Benn CS, Balé C, Sommerfelt H, Friis H, Aaby P. Vitamin A supplementation and childhood mortality: amplification of the non-specific effects of vaccines? Int J Epidemiol 2003;32:822-8. - PubMed
    1. Humphrey JH, Agoestina T, Wu L, Usman A, Nurachim M, Subardja D, et al. Impact of neonatal vitamin A supplementation on infant morbidity and mortality. J Pediatr 1996;128:489-96. - PubMed
    1. Rahmathullah L, Tielsch JM, Thulasiraj RD, Katz J, Coles C, Devi S, et al. Impact of supplementing newborn infants with vitamin A on early infant mortality: community based randomised trial in southern India. BMJ 2003;327:254. - PMC - PubMed
    1. Benn CS, Martins C, Rodrigues A, Jensen H, Lisse IM, Aaby P. Randomised study of the impact of different doses of vitamin A on childhood morbidity and mortality. BMJ 2005;331:1428-32. - PMC - PubMed

Publication types

Associated data