Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
NCT00944359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7680
Last updated 2018-07-13
Summary
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Daily preventive Zn; placebo treatment
7 mg zinc / day and placebo supplement during diarrhea episodes
- DIETARY_SUPPLEMENT
-
Therapeutic Zn; daily placebo
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
- DIETARY_SUPPLEMENT
-
Intermittent Zn; placebo treatment
10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes
- OTHER
-
Surveillance control group
Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
Sponsors & Collaborators
-
Université Polytechnique de Bobo-Dioulasso
collaborator OTHER -
Helen Keller International
collaborator OTHER -
Thrasher Research Fund
collaborator OTHER -
Canadian International Development Agency
collaborator OTHER_GOV -
University of California, Davis
lead OTHER
Principal Investigators
-
Kenneth H Brown, MD · University of California, Davis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 27 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2012-02-29
- Completion
- 2012-02-29
Countries
- Burkina Faso
Study Locations
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