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


METHODS
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.


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


METHODS
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.


BACKGROUND
Clinical trials NCT00168597.
Benn
Christine Stabell
CS
Bandim Health Project, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark. cb@ssi.dk
Diness
Birgitte Rode
BR
Roth
Adam
A
Nante
Ernesto
E
Fisker
Ane Baerent
AB
Lisse
Ida Maria
IM
Yazdanbakhsh
Maria
M
Whittle
Hilton
H
Rodrigues
Amabelia
A
Aaby
Peter
P
D001500:BCG Vaccine / Q000008:administration & dosage*; D002423:Cause of Death; D005260:Female; D006169:Guinea-Bissau / Q000453:epidemiology; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D008297:Male; D012621:Seasons; D017678:Sex Distribution; D015996:Survival Rate; D014801:Vitamin A / Q000008:administration & dosage*; D014815:Vitamins / Q000008:administration & dosage*
D001500:BCG Vaccine; D014815:Vitamins; D014801:Vitamin A