Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

January 30, 2013 updated by: Kintampo Health Research Centre, Ghana

Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

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
    • Brong Ahafo
      • Kintampo, Brong Ahafo, Ghana
        • Kintampo Health Research Centre

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

6 months to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin A and zinc
combination of vitamin A and zinc supplements
Dietary supplement: vitamin A and zinc
combination of vitamin A and zinc supplements
Active Comparator: Vitamin A and placebo
vitamin A with placebo
Dietary supplement: vitamin A
vitamin A with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of clinical malaria attacks
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Kintampo Health Research Centre, Ghana

Collaborators

University of Wisconsin, Madison
International Atomic Energy Agency

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

March 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 27, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

February 1, 2013

Last Update Submitted That Met QC Criteria

January 30, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMANI

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.

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