Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malaria, Malnutrition

Intervention / Treatment
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* Dietary Supplement: vitamin A
* Dietary Supplement: vitamin A and zinc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin A and zinc<br>combination of vitamin A and zinc supplements | Dietary Supplement: vitamin A and zinc<br>* combination of vitamin A and zinc supplements<br>|
| Active Comparator: Vitamin A and placebo<br>vitamin A with placebo | Dietary Supplement: vitamin A<br>* vitamin A with placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of clinical malaria attacks |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin A, Zinc, Malaria, Morbidity, MRDR