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Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

Primary Purpose

Malaria, Malnutrition

Status
Completed
Phase
Phase 3
Locations
Ghana
Study Type
Interventional
Intervention
vitamin A
vitamin A and zinc
Sponsored by
Kintampo Health Research Centre, Ghana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Vitamin A, Zinc, Malaria, Morbidity, MRDR

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kintampo Health Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin A and zinc

Vitamin A and placebo

Arm Description

combination of vitamin A and zinc supplements

vitamin A with placebo

Outcomes

Primary Outcome Measures

incidence of clinical malaria attacks

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2013
Last Updated
January 30, 2013
Sponsor
Kintampo Health Research Centre, Ghana
Collaborators
International Atomic Energy Agency, University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01782001
Brief Title
Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity
Official Title
Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kintampo Health Research Centre, Ghana
Collaborators
International Atomic Energy Agency, University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Malnutrition
Keywords
Vitamin A, Zinc, Malaria, Morbidity, MRDR

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin A and zinc
Arm Type
Experimental
Arm Description
combination of vitamin A and zinc supplements
Arm Title
Vitamin A and placebo
Arm Type
Active Comparator
Arm Description
vitamin A with placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin A
Intervention Description
vitamin A with placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin A and zinc
Intervention Description
combination of vitamin A and zinc supplements
Primary Outcome Measure Information:
Title
incidence of clinical malaria attacks
Time Frame
6 months
Secondary Outcome Measure Information:
Title
changes in weight and height/length
Description
Enrollment and end of supplementation
Time Frame
baseline and 6 months
Title
changes in vitamin A and zinc nutritional status within and between the groups
Description
enrollment and end of supplementation
Time Frame
baseline and 6 months
Title
change in prevalence of anemia
Description
enrollment and end of supplementation
Time Frame
baseline and 6 months
Title
the incidence of diarrhea and pneumonia
Description
1 time/week, enrollment to end, total:24
Time Frame
1 time per week up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Owusu-Agyei, PhD
Organizational Affiliation
Kintampo Health Research Centre, Ghana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kintampo Health Research Centre
City
Kintampo
State/Province
Brong Ahafo
Country
Ghana

12. IPD Sharing Statement

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Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

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