Vitamin A With BCG Vaccine

Summary

Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.

Timeline

Start

2002-08

Primary completion

2013-11

Completion

—

Outcome

Missed primary endpoint

paper Vitamin A supplementation was not significantly associated with mortality; the mortality rate ratio was 1.07 (95% confidence interval 0.79 to 1.44). PMID 18558641 ↗

Publications

• Aage S, Kiraly N, Da Costa K, Byberg S, Bjerregaard-Andersen M, Fisker AB, Aaby P, Benn CS. Neonatal vitamin A supplementation associated with increased atopy in girls. Allergy. 2015 Aug;70(8):985-94. doi: 10.1111/all.12641. Epub 2015 May 18.
• Benn CS, Martins CL, Fisker AB, Diness BR, Garly ML, Balde I, Rodrigues A, Whittle H, Aaby P. Interaction between neonatal vitamin A supplementation and timing of measles vaccination: a retrospective analysis of three randomized trials from Guinea-Bissau. Vaccine. 2014 Sep 22;32(42):5468-74. doi: 10.1016/j.vaccine.2014.07.090. Epub 2014 Aug 13.
• Fisker AB, Aaby P, Rodrigues A, Frydenberg M, Bibby BM, Benn CS. Vitamin A supplementation at birth might prime the response to subsequent vitamin A supplements in girls. Three year follow-up of a randomized trial. PLoS One. 2011;6(8):e23265. doi: 10.1371/journal.pone.0023265. Epub 2011 Aug 11.
• Diness BR, Christoffersen D, Pedersen UB, Rodrigues A, Fischer TK, Andersen A, Whittle H, Yazdanbakhsh M, Aaby P, Benn CS. The effect of high-dose vitamin A supplementation given with bacille Calmette-Guerin vaccine at birth on infant rotavirus infection and diarrhea: a randomized prospective study from Guinea-Bissau. J Infect Dis. 2010 Sep 1;202 Suppl:S243-51. doi: 10.1086/653569.
• Benn CS, Diness BR, Roth A, Nante E, Fisker AB, Lisse IM, Yazdanbakhsh M, Whittle H, Rodrigues A, Aaby P. Effect of 50,000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial. BMJ. 2008 Jun 21;336(7658):1416-20. doi: 10.1136/bmj.39542.509444.AE. Epub 2008 Jun 16.
• Diness BR, Fisker AB, Roth A, Yazdanbakhsh M, Sartono E, Whittle H, Nante JE, Lisse IM, Ravn H, Rodrigues A, Aaby P, Benn CS. Effect of high-dose vitamin A supplementation on the immune response to Bacille Calmette-Guerin vaccine. Am J Clin Nutr. 2007 Oct;86(4):1152-9. doi: 10.1093/ajcn/86.4.1152.
• Fisker AB, Lisse IM, Aaby P, Erhardt JG, Rodrigues A, Bibby BM, Benn CS. Effect of vitamin A supplementation with BCG vaccine at birth on vitamin A status at 6 wk and 4 mo of age. Am J Clin Nutr. 2007 Oct;86(4):1032-9. doi: 10.1093/ajcn/86.4.1032.

Drugs

Indications

No indication recorded.