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 S. Benn

doi:10.1542/peds.2014-0550

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 S. Benn

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

41 Citations (Scopus)

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 (100 000 IU if aged 6-11 months, 200 000 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.

Original language	English
Journal	Pediatrics
Volume	134
Issue number	3
Pages (from-to)	e739-e748
ISSN	0031-4005
DOIs	https://doi.org/10.1542/peds.2014-0550
Publication status	Published - 1 Sept 2014
Externally published	Yes

Keywords

Child mortality
Randomized controlled trial
Vaccinations
Vitamin A supplementation

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@article{eaaa2012f621400598563caba95b706d,

title = "High-dose vitamin A with vaccination after 6 months of age: A randomized trial",

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 (100 000 IU if aged 6-11 months, 200 000 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.",

keywords = "Child mortality, Randomized controlled trial, Vaccinations, Vitamin A supplementation",

author = "Fisker, {Ane B.} and Carlito Bale and Amabelia Rodrigues and Ibraima Balde and Manuel Fernandes and J{\o}rgensen, {Mathias J.} and Niels Danneskiold-Sams{\o}e and Linda Hornsh{\o}j and Julie Rasmussen and Christensen, {Emil D.} and Bibby, {Bo M.} and Peter Aaby and Benn, {Christine S.}",

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doi = "10.1542/peds.2014-0550",

language = "English",

volume = "134",

pages = "e739--e748",

journal = "Pediatrics",

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TY - JOUR

T1 - High-dose vitamin A with vaccination after 6 months of age

T2 - A randomized trial

AU - Fisker, Ane B.

AU - Bale, Carlito

AU - Rodrigues, Amabelia

AU - Balde, Ibraima

AU - Fernandes, Manuel

AU - Jørgensen, Mathias J.

AU - Danneskiold-Samsøe, Niels

AU - Hornshøj, Linda

AU - Rasmussen, Julie

AU - Christensen, Emil D.

AU - Bibby, Bo M.

AU - Aaby, Peter

AU - Benn, Christine S.

PY - 2014/9/1

Y1 - 2014/9/1

N2 - 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 (100 000 IU if aged 6-11 months, 200 000 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.

AB - 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 (100 000 IU if aged 6-11 months, 200 000 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.

KW - Child mortality

KW - Randomized controlled trial

KW - Vaccinations

KW - Vitamin A supplementation

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DO - 10.1542/peds.2014-0550

M3 - Journal article

C2 - 25136048

AN - SCOPUS:84907189550

SN - 0031-4005

VL - 134

SP - e739-e748

JO - Pediatrics

JF - Pediatrics

IS - 3

ER -

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

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