BMJ  2008;336:1416-1420 (21 June), doi:10.1136/bmj.39542.509444.AE (published 16 June 2008)

Research

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

¹ Bandim Health Project, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark , ² Department of Medical Microbiology, Lund University, 205 02 Malmö, Sweden , ³ Bandim Health Project, Indepth Network, Apartado 861, Bissau, Guinea-Bissau , ⁴ Department of Pathology, Herlev University Hospital, 2730 Herlev, Denmark , ⁵ Department of Immunoparasitology, Leiden University Medical Centre, Leiden 2333 AZ, Netherlands , ⁶ MRC Laboratories, Fajara, POB 273, Gambia

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 [ClinicalTrials.gov] .

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