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Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial.

Abstract：

OBJECTIVE:To investigate the effect of vitamin A supplementation and BCG vaccination at birth in low birthweight neonates. DESIGN:Randomised, placebo controlled, two by two factorial trial. SETTING:Bissau, Guinea-Bissau. PARTICIPANTS:1717 low birthweight neonates born at the national hospital. INTERVENTION:Neonates who weighed less than 2.5 kg were randomly assigned to 25 000 IU vitamin A or placebo, as well as to early BCG vaccine or the usual late BCG vaccine, and were followed until age 12 months. MAIN OUTCOME MEASURE:Mortality, calculated as mortality rate ratios (MRRs), after follow-up to 12 months of age for infants who received vitamin A supplementation compared with those who received placebo. RESULTS:No interaction was observed between vitamin A supplementation and BCG vaccine allocation (P=0.73). Vitamin A supplementation at birth was not significantly associated with mortality: the MRR of vitamin A supplementation compared with placebo, controlled for randomisation to "early BCG" versus "no early BCG" was 1.08 (95% CI 0.79 to 1.47). Stratification by sex revealed a significant interaction between vitamin A supplementation and sex (P=0.046), the MRR of vitamin A supplementation being 0.74 (95% CI 0.45 to 1.22) in boys and 1.42 (95% CI 0.94 to 2.15) in girls. When these data were combined with data from a complementary trial among normal birthweight neonates in Guinea-Bissau, the combined estimate of the effect of neonatal vitamin A supplementation on mortality was 1.08 (95% CI 0.87 to 1.33); 0.80 (95% CI 0.58 to 1.10) in boys and 1.41 (95% CI 1.04 to 1.90) in girls (P=0.01 for interaction between neonatal vitamin A and sex). CONCLUSIONS:The combined results of this trial and the complementary trial among normal birthweight neonates have now shown that, overall, it would not be beneficial to implement a neonatal vitamin A supplementation policy in Guinea-Bissau. Worryingly, the trials show that vitamin A supplementation at birth can be harmful in girls. Previous studies and future trials should investigate the possibility that vitamin A supplementation has sex differential effects. Trial registration ClinicalTrials.gov NCT00168610.

journal_name

BMJ

journal_title

BMJ (Clinical research ed.)

authors

Benn CS,Fisker AB,Napirna BM,Roth A,Diness BR,Lausch KR,Ravn H,Yazdanbakhsh M,Rodrigues A,Whittle H,Aaby P

doi

10.1136/bmj.c1101

subject

Has Abstract

pub_date

2010-03-09 00:00:00

pages

c1101

eissn

0959-8138

issn

1756-1833

journal_volume

340

pub_type

杂志文章,多中心研究,随机对照试验

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Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial.