Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

Phase 3

Completed

• Conditions: Malaria; Malnutrition
• Interventions: Dietary Supplement: vitamin A and zinc; Dietary Supplement: vitamin A

• Registration Number: NCT01782001
• Lead Sponsor: Kintampo Health Research Centre, Ghana

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2013-01
• Study First Submitted: 2013-01-27
• Study First Submitted QC: 2013-01-30
• Last Update Submitted: 2013-01-30
• Study First Posted: 2013-02-01
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin A and zinc	vitamin A and zinc	combination of vitamin A and zinc supplements
Vitamin A and placebo	vitamin A	vitamin A with placebo

Primary Outcome Measures

Name	Time	Method
incidence of clinical malaria attacks	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kintampo Health Research Centre; 🇬🇭 Kintampo, Brong Ahafo, Ghana