Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

Overview

The purpose of this study was to determine whether young children receiving Vitamin A and Zinc supplements will have a lower incidence of symptomatic malaria than similar children receiving vitamin A supplements alone.

Full Title of Study: “Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2009

Detailed Description

The aim of our study was to determine the impact of the combination of vitamin A and zinc supplements on malaria morbidity in young children. The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria. The specific objectives were to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on changes in anthropometric measurements specifically weight and length/height and to assess the effect of the study interventions on the incidence of anemia, diarrhea and pneumonia. It also assessed the tolerability of the supplements and determined the change in zinc status by measuring plasma zinc concentration using atomic absorption spectrometry before and at the end of the intervention. The study also determined the change in vitamin A status as assessed by the modified relative dose response (MRDR) test during and at the end of the intervention.

Interventions

  • Dietary Supplement: vitamin A
    • vitamin A with placebo
  • Dietary Supplement: vitamin A and zinc
    • combination of vitamin A and zinc supplements

Arms, Groups and Cohorts

  • Experimental: Vitamin A and zinc
    • combination of vitamin A and zinc supplements
  • Active Comparator: Vitamin A and placebo
    • vitamin A with placebo

Clinical Trial Outcome Measures

Primary Measures

  • incidence of clinical malaria attacks
    • Time Frame: 6 months

Secondary Measures

  • changes in weight and height/length
    • Time Frame: baseline and 6 months
    • Enrollment and end of supplementation
  • changes in vitamin A and zinc nutritional status within and between the groups
    • Time Frame: baseline and 6 months
    • enrollment and end of supplementation
  • change in prevalence of anemia
    • Time Frame: baseline and 6 months
    • enrollment and end of supplementation
  • the incidence of diarrhea and pneumonia
    • Time Frame: 1 time per week up to 6 months
    • 1 time/week, enrollment to end, total:24

Participating in This Clinical Trial

Inclusion Criteria

  • Children aged 6 – 24 months – Child's guardian is willing to provide informed consent – Child's family plans to remain resident in the study areas during the study period Exclusion Criteria:

  • Clinical evidence of vitamin A deficiency – Severe acute malnutrition – Severe illness – Child aged <6 months or >24 months – Receipt of vitamin A supplement within the last three months

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kintampo Health Research Centre, Ghana
  • Collaborator
    • International Atomic Energy Agency
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seth Owusu-Agyei, PhD, Principal Investigator, Kintampo Health Research Centre, Ghana

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