Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso

Conditions
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Diarrhea, Malaria, Zinc Deficiency

Intervention / Treatment
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* Dietary Supplement: Daily preventive Zn; placebo treatment
* Dietary Supplement: Therapeutic Zn; daily placebo
* Dietary Supplement: Intermittent Zn; placebo treatment
* Other: Surveillance control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 27 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily preventive Zn; placebo treatment<br>7 mg zinc per day for 12 months and placebo supplement during diarrhea episode | Dietary Supplement: Daily preventive Zn; placebo treatment<br>* 7 mg zinc / day and placebo supplement during diarrhea episodes<br>* Other names: Nutriset preventive zinc and therapeutic placebo supplement;|
| Experimental: Therapeutic Zn; daily placebo<br>20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement | Dietary Supplement: Therapeutic Zn; daily placebo<br>* 20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement<br>* Other names: Nutriset ZinCfant;|
| Experimental: Intermittent Zn; placebo treatment<br>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<br>* 10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes<br>* Other names: Nutriset zinc supplement;|
| Active Comparator: Surveillance control group<br>Surveillance control group will be randomly assigned to intervention groups every 3 months | Other: Surveillance control group<br>* Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months<br>|
| No Intervention: Non-intervention<br>Standard care provided by health system | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stunting, underweight, and wasting |  | 12 months | 
| Change in hemoglobin and iron status |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zinc supplementation, diarrhea management, zinc deficiency, malaria