Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

Not Applicable

Completed

• Conditions: Zinc Deficiency; Diarrhea; Malaria
• Interventions: Dietary Supplement: Daily preventive Zn; placebo treatment; Dietary Supplement: Therapeutic Zn; daily placebo; Dietary Supplement: Intermittent Zn; placebo treatment; Other: Surveillance control group

• Registration Number: NCT00944359
• Lead Sponsor: University of California, Davis

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.

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 Timeline

• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-23
• Study Start: 2010-12
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7680

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily preventive Zn; placebo treatment	Daily preventive Zn; placebo treatment	7 mg zinc per day for 12 months and placebo supplement during diarrhea episode
Therapeutic Zn; daily placebo	Therapeutic Zn; daily placebo	20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement
Intermittent Zn; placebo treatment	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
Surveillance control group	Surveillance control group	Surveillance control group will be randomly assigned to intervention groups every 3 months

Primary Outcome Measures

Name	Time	Method
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
Change in length and length-for-age Z-score	12 months

Secondary Outcome Measures

Name	Time	Method
Change in hemoglobin and iron status	12 months
Incidence of stunting, underweight, and wasting	12 months

Trial Locations

Locations (1)

Institut de Recherche en Science de la Sante; 🇧🇫 Bobo-Dioulasso, Burkina Faso