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  • Effect of vitamin A supplementation in women of reproductive age on cause-specific early and late infant mortality in rural Ghana: ObaapaVitA double-blind, cluster-randomised, placebo-controlled trial

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Paediatrics
Research
Effect of vitamin A supplementation in women of reproductive age on cause-specific early and late infant mortality in rural Ghana: ObaapaVitA double-blind, cluster-randomised, placebo-controlled trial
  1. Karen Edmond1,
  2. Lisa Hurt1,
  3. Justin Fenty2,
  4. Seeba Amenga-Etego3,
  5. Charles Zandoh3,
  6. Chris Hurt4,
  7. Samuel Danso3,
  8. Charlotte Tawiah3,
  9. Zelee Hill5,
  10. Augustinus H A ten Asbroek1,
  11. Seth Owusu-Agyei3,
  12. Oona Campbell1,
  13. Betty R Kirkwood1
  1. 1Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
  2. 2Nottingham Clinical Trials Unit, Institute of Clinical Research, University of Nottingham, Nottingham, UK
  3. 3Faculty of Epidemiology and Population Health, Kintampo Health Research Centre, Ministry of Health, Kintampo, Ghana
  4. 4Wales Cancer Trials Unit, Cardiff University, Cardiff, UK
  5. 5Faculty of Epidemiology and Population Health, Institute of Child Health, University College London, London, UK
  1. Correspondence to Dr Karen Edmond; karen.edmond{at}lshtm.ac.uk

Abstract

Objectives To assess the effect of vitamin A supplementation in women of reproductive age in Ghana on cause- and age-specific infant mortality. In addition, because of recently published studies from Guinea Bissau, effects on infant mortality by sex and season were assessed.

Design Double-blind, cluster-randomised, placebo-controlled trial.

Setting 7 contiguous districts in the Brong Ahafo region of Ghana.

Participants All women of reproductive age (15–45 years) resident in the study area randomised by cluster of residence. All live born infants from 1 June 2003 to 30 September 2008 followed up through 4-weekly home visits.

Intervention Weekly low-dose (25 000 IU) vitamin A.

Main outcome measures Early infant mortality (1–5 months); late infant mortality (6–11 months); infection-specific infant mortality (0–11 months).

Results 1086 clusters, 62 662 live births, 52 574 infant-years and 3268 deaths yielded HRs (95% CIs) comparing weekly vitamin A with placebo: 1.04 (0.88 to 1.05) early infant mortality; 0.99 (0.84 to 1.18) late infant mortality; 1.03 (0.92 to 1.16) infection-specific infant mortality. There was no evidence of modification of the effect of vitamin A supplementation on infant mortality by sex (Wald statistic =0.07, p=0.80) or season (Wald statistic =0.03, p=0.86).

Conclusions This is the largest analysis of cause of infant deaths from Africa to date. Weekly vitamin A supplementation in women of reproductive age has no beneficial or deleterious effect on the causes of infant death to age 6 or 12 months in rural Ghana.

Trial registration number http://ClinicalTrials.gov: NCT00211341.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

https://doi.org/10.1136/bmjopen-2011-000658

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    Footnotes

    • All authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

    • To cite: Edmond K, Hurt L, Fenty J, et al. Effect of vitamin A supplementation in women of reproductive age on cause-specific early and late infant mortality in rural Ghana: ObaapaVitA double-blind, cluster-randomised, placebo-controlled trial. BMJ Open 2012;2:e000658. doi:10.1136/bmjopen-2011-000658

    • Funding This document is an output from a project funded by the UK Department for International Development (DFID) for the benefit of developing countries; the views expressed are not necessarily those of DFID. In addition, United States Agency for International Development contributed some funding to the initial stages of the trial, and Roche kindly donated the vitamin A palmitate for the capsules. The researchers are fully independent from the funders. The study funders had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; nor in the decision to submit the article for publication.

    • Competing interests All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and we declare that all authors have no financial or non-financial interests that may be relevant to the submitted work.

    • Ethics approval Ethics approval was provided by Kintampo Health Research Centre, Ghana Health Service, London School of Hygiene and Tropical Medicine.

    • Contributors The paper was drafted by KE, LH and BRK and reviewed by all authors. The late Paul Arthur, BRK and OC designed the study. KE, LH, AHAtA and SO-A were responsible for trial conduct. ZH and CT participated in design and management of the Information, Education and Communication component of the trial. SA-E, SD, BRK, CH and JF participated in design and management of the data management system. CZ coordinated the fieldwork. LH, CH and JF undertook the statistical analyses. BRK is the guarantor for the study.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data available.