Malaria, Malnutrition
Conditions
Keywords
Vitamin A, Zinc, Malaria, Morbidity, MRDR
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.
Interventions
DIETARY_SUPPLEMENTvitamin A
vitamin A with placebo
DIETARY_SUPPLEMENTvitamin A and zinc
combination of vitamin A and zinc supplements
Sponsors
International Atomic Energy Agency
University of Wisconsin, Madison
Kintampo Health Research Centre, Ghana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of clinical malaria attacks | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in weight and height/length | baseline and 6 months | Enrollment and end of supplementation |
| changes in vitamin A and zinc nutritional status within and between the groups | baseline and 6 months | enrollment and end of supplementation |
| change in prevalence of anemia | baseline and 6 months | enrollment and end of supplementation |
| the incidence of diarrhea and pneumonia | 1 time per week up to 6 months | 1 time/week, enrollment to end, total:24 |
Countries
Ghana
Outcome results
None listed