Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Daily preventive Zn; placebo treatment 7 mg zinc per day for 12 months and placebo supplement during diarrhea episode |
Dietary Supplement: Daily preventive Zn; placebo treatment
7 mg zinc / day and placebo supplement during diarrhea episodes
Other Names:
|
| Experimental: Therapeutic Zn; daily placebo 20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement |
Dietary Supplement: Therapeutic Zn; daily placebo
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
Other Names:
|
| Experimental: Intermittent Zn; placebo treatment 10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode |
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 Names:
|
| Active Comparator: Surveillance control group Surveillance control group will be randomly assigned to intervention groups every 3 months |
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
|
| No Intervention: Non-intervention Standard care provided by health system |
Outcome Measures
Primary Outcome Measures
- Change in length and length-for-age Z-score [12 months]
- Change in weight and weight-for-age [12 months]
- Incidence of diarrhea and laboratory-confirmed malaria [12 months]
- Change in plasma zinc concentration [12 months]
Secondary Outcome Measures
- Incidence of stunting, underweight, and wasting [12 months]
- Change in hemoglobin and iron status [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
6-27 months of age
-
Plan to remain in study area for 1 year
Exclusion Criteria:
-
Evidence of congenital abnormalities and chronic infection
-
Severe anemia and severe acute malnutrition
-
Consumption of micronutrient supplementation including zinc
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de Recherche en Science de la Sante | Bobo-Dioulasso | Burkina Faso |
Sponsors and Collaborators
- University of California, Davis
- Université Polytechnique de Bobo-Dioulasso
- Helen Keller International
- Thrasher Research Fund
- Canadian International Development Agency
Investigators
- Principal Investigator: Kenneth H Brown, MD, University of California, Davis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 222218
- Zinc 7-20