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

Phase 3

Completed

• Conditions: Malaria

• Registration Number: NCT02878265
• Lead Sponsor: University of Ghana

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-19
• Last Update Submitted: 2016-08-19
• Study First Posted: 2016-08-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 547

Inclusion Criteria

• under 5years
• will stay in the community for 10years

Exclusion Criteria

• chronic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Amoako; 🇬🇭 Accra, Ghana