Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial
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.Intervent...
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Published in | BMJ Vol. 340; no. 7747; p. 636 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
British Medical Journal Publishing Group
09.03.2010
British Medical Association BMJ Publishing Group LTD BMJ Publishing Group Ltd |
Subjects | |
Online Access | Get full text |
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Summary: | 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. |
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Bibliography: | local:bmj;340/mar09_1/c1101 istex:731A032AF31EA70CAF14185E33D3E4A89A09AEA9 PMID:20215360 href:bmj-340-bmj-c1101.pdf ArticleID:benc749580 ark:/67375/NVC-Z31JR7BJ-Z ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23 |
ISSN: | 0959-8138 1756-1833 1468-5833 1756-1833 |
DOI: | 10.1136/bmj.c1101 |