Malaria Clinical Trial
Official title:
Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso
Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency
or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to
determine how best to integrate programs designed either to prevent zinc deficiency or to
treat diarrhea.
The overall objective of this project is to determine the most effective approach to prevent
zinc deficiency and treat diarrhea, such that a single approach could provide the maximal
beneficial impact on the health and nutritional status of young children and greatest
simplicity of implementation.
This is a single-center cluster- and household-randomized, partially masked, community-based
efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one
region, with 34 clusters randomly assigned to 3 types of intervention communities.
Communities will be randomly assigned to 1) early intervention communities, 2) later
intervention communities, 3) non-intervention communities. Within each intervention cluster,
children will be randomly assigned to the intervention group at the household level. Children
aged 6-27 months at enrollment will be eligible. The study duration is 12 months.
The investigators will assess the relative impact of daily preventive zinc supplementation (7
mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days
every three months for one year), and zinc treatment during episodes of diarrhea (20 mg
zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that
will be assessed include the incidence and duration of all episodes of diarrhea, the
incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc,
iron and vitamin A status.
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