The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children

Overview

The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

Detailed Description

A total of 542 children aged between 6-59 months received either: (i) VA (control) or (ii) VA & Z (VAZ) or (iii) VA, Z & MV (VAZM). VA was delivered as a single dose while MV and Z were delivered daily. Malaria cases were managed by community health workers, who used rapid diagnostic test to confirm infection prior to treatment.

Interventions

  • Dietary Supplement: Vitamin A
    • Vitamin A supplements
  • Dietary Supplement: Vitamin A and ZInc
    • Combination of vitamin A and zinc supplements
  • Dietary Supplement: Vitamin A , Zinc and Multivitamin
    • Combination of vitamin A, zinc and multivitamins

Arms, Groups and Cohorts

  • Placebo Comparator: Vitamin A
    • A single dose of 20,000IU Vitamin A for the whole study period
  • Active Comparator: Vitamin A and zinc
    • A single dose of 20,000IU Vitamin A and 10mg of elemental zinc each day for 5 months
  • Active Comparator: Vitamin A , Zinc and Multivitamin
    • A single dose of 20,000IU Vitamin A , 10mg of elemental zinc each day and 0.5ml/kg multivitamin syrup for 5 months

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of clinical malaria attacks
    • Time Frame: Baseline and every month up to six months
    • While taking the supplement, malaria incidence will be measured

Secondary Measures

  • Incidence of diarrhea attacks
    • Time Frame: Every month up to six months
    • While taking the supplement, diarrhea incidence will be measured

Participating in This Clinical Trial

Inclusion Criteria

  • under 5years – will stay in the community for 10years Exclusion Criteria:

  • chronic diseases

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Ghana
  • Collaborator
    • Kwame Nkrumah University of Science and Technology
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wilhelmina Annie Mensah, Ms – University of Ghana
  • Overall Official(s)
    • Patricia k Brown, PhD, Study Chair, Kwame Nkrumah Univeristy of Science and Technolgy
    • Wilhelmina A Mensah, Mphil, Principal Investigator, University of Ghana

References

Veenemans J, Milligan P, Prentice AM, Schouten LR, Inja N, van der Heijden AC, de Boer LC, Jansen EJ, Koopmans AE, Enthoven WT, Kraaijenhagen RJ, Demir AY, Uges DR, Mbugi EV, Savelkoul HF, Verhoef H. Effect of supplementation with zinc and other micronutrients on malaria in Tanzanian children: a randomised trial. PLoS Med. 2011 Nov;8(11):e1001125. doi: 10.1371/journal.pmed.1001125. Epub 2011 Nov 22.

Citations Reporting on Results

Zeba AN, Sorgho H, Rouamba N, Zongo I, Rouamba J, Guiguemde RT, Hamer DH, Mokhtar N, Ouedraogo JB. Major reduction of malaria morbidity with combined vitamin A and zinc supplementation in young children in Burkina Faso: a randomized double blind trial. Nutr J. 2008 Jan 31;7:7. doi: 10.1186/1475-2891-7-7.

Owusu-Agyei S, Newton S, Mahama E, Febir LG, Ali M, Adjei K, Tchum K, Alhassan L, Moleah T, Tanumihardjo SA. Impact of vitamin A with zinc supplementation on malaria morbidity in Ghana. Nutr J. 2013 Sep 23;12:131. doi: 10.1186/1475-2891-12-131.

Imdad A, Herzer K, Mayo-Wilson E, Yakoob MY, Bhutta ZA. Vitamin A supplementation for preventing morbidity and mortality in children from 6 months to 5 years of age. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008524. doi: 10.1002/14651858.CD008524.pub2.

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