Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity
Information source: Kintampo Health Research Centre, Ghana
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria; Malnutrition
Intervention: vitamin A (Dietary Supplement); vitamin A and zinc (Dietary Supplement)
Phase: Phase 3
Status: Completed
Sponsored by: Kintampo Health Research Centre, Ghana Official(s) and/or principal investigator(s): Seth Owusu-Agyei, PhD, Principal Investigator, Affiliation: Kintampo Health Research Centre, Ghana
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.
Clinical Details
Official title: Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: incidence of clinical malaria attacks
Secondary outcome: changes in weight and height/lengthchanges in vitamin A and zinc nutritional status within and between the groups change in prevalence of anemia the incidence of diarrhea and pneumonia
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.
Eligibility
Minimum age: 6 Months.
Maximum age: 24 Months.
Gender(s): Both.
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
Locations and Contacts
Kintampo Health Research Centre, Kintampo, Brong Ahafo, Ghana
Additional Information
Starting date: March 2009
Last updated: January 30, 2013
|