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

August 19, 2016 updated by: Wilhelmina Annie Mensah, University of Ghana
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

547

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Accra, Ghana, 233
        • Amoako

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vitamin A
A single dose of 20,000IU Vitamin A for the whole study period
Dietary supplement: Vitamin A
Vitamin A supplements
Other Names:
  • VA
Active Comparator: Vitamin A and zinc
A single dose of 20,000IU Vitamin A and 10mg of elemental zinc each day for 5 months
Dietary supplement: Vitamin A and ZInc
Combination of vitamin A and zinc supplements
Other Names:
  • VAZ
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
Dietary supplement: Vitamin A , Zinc and Multivitamin
Combination of vitamin A, zinc and multivitamins
Other Names:
  • VAZM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ghana

Collaborators

Kwame Nkrumah University of Science and Technology

Investigators

  • Study Chair: Patricia k Brown, PhD, Kwame Nkrumah Univeristy of Science and Technolgy
  • Principal Investigator: Wilhelmina A Mensah, Mphil, University of Ghana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAZ20016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To meet the participants and explain the results of their data to them

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malaria

Clinical Trials on Vitamin A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe