Format

Send to

Choose Destination
See comment in PubMed Commons below
Pediatrics. 2014 Sep;134(3):e739-48. doi: 10.1542/peds.2014-0550.

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

Author information

1
Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark; Department of Biostatistics, Institute of Public Health, University of Aarhus, Aarhus, Denmark; and a.fisker@bandim.org.
2
Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau;
3
Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark;
4
Department of Biostatistics, Institute of Public Health, University of Aarhus, Aarhus, Denmark; and.
5
Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark;
6
Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark; Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00514891.

KEYWORDS:

child mortality; randomized controlled trial; vaccinations; vitamin A supplementation

PMID:
25136048
DOI:
10.1542/peds.2014-0550
[Indexed for MEDLINE]
Free full text
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for HighWire
    Loading ...
    Support Center