High-dose vitamin A with vaccination after 6 months of age: a randomized trial

Ane B Fisker, Carlito Bale, Amabelia Rodrigues, Ibraima Balde, Manuel Fernandes, Mathias J Jørgensen, Niels Danneskiold-Samsøe, Linda Hornshøj, Julie Rasmussen, Emil D Christensen, Bo M Bibby, Peter Aaby, Christine Stabell Benn

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstract

BACKGROUND: The World Health Organization recommends vitamin A supplementation (VAS) at routine vaccination contacts after 6 months of age based on the assumption that it reduces mortality by 24%. The policy has never been evaluated in randomized controlled trials for its effect on overall mortality. We conducted a randomized double-blind trial to evaluate the effect of VAS with vaccines.

METHODS: We randomized children aged 6 to 23 months 1:1 to VAS (100000 IU if aged 6-11 months, 200000 IU if aged 12-23 months) or placebo at vaccination contacts in Guinea-Bissau. Mortality rates were compared in Cox proportional-hazards models overall, and by gender and vaccine.

RESULTS: Between August 2007 and November 2010, 7587 children were enrolled. Within 6 months of follow-up 80 nonaccident deaths occurred (VAS: 38; placebo: 42). The mortality rate ratio (MRR) comparing VAS versus placebo recipients was 0.91 (95% confidence interval 0.59-1.41) and differed significantly between boys (MRR 1.92 [0.98-3.75]) and girls (MRR 0.45 [0.24-0.87]) (P = .003 for interaction between VAS and gender). At enrollment, 42% (3161/7587) received live measles vaccine, 29% (2154/7587) received inactivated diphtheria-tetanus-pertussis-containing vaccines, and 21% (1610/7587) received both live and inactivated vaccines. The effect of VAS did not differ by vaccine group.

CONCLUSIONS: This is the first randomized controlled trial to assess the effect of the policy on overall mortality. VAS had no overall effect, but the effect differed significantly by gender. More trials to ensure an optimal evidence-based vitamin A policy are warranted.

OriginalsprogEngelsk
TidsskriftPediatrics
Vol/bind134
Udgave nummer3
Sider (fra-til)e739-e748
ISSN0031-4005
DOI
StatusUdgivet - sep. 2014

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