Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Zinc Deficiency Diarrhea Malaria |
Dietary Supplement: Daily preventive Zn; placebo treatment Dietary Supplement: Therapeutic Zn; daily placebo Dietary Supplement: Intermittent Zn; placebo treatment Other: Surveillance control group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso |
- Change in length and length-for-age Z-score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in weight and weight-for-age [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Incidence of diarrhea and laboratory-confirmed malaria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in plasma zinc concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Incidence of stunting, underweight, and wasting [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in hemoglobin and iron status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 7680 |
| Study Start Date: | December 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Nutriset preventive zinc and therapeutic placebo supplement
|
|
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 Name: Nutriset ZinCfant
|
|
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 Name: Nutriset zinc supplement
|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 6 Months to 27 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Burkina Faso | |
| Institut de Recherche en Science de la Sante | |
| Bobo-Dioulasso, Burkina Faso | |
| Principal Investigator: | Kenneth H Brown, MD | University of California, Davis |
More Information
No publications provided
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00944359 History of Changes |
| Other Study ID Numbers: | 222218, Zinc 7-20 |
| Study First Received: | July 21, 2009 |
| Last Updated: | December 7, 2012 |
| Health Authority: | Burkina Faso: Ministry of Health |
Keywords provided by University of California, Davis:
|
zinc supplementation diarrhea management zinc deficiency malaria |
Additional relevant MeSH terms:
|
Diarrhea Malaria Signs and Symptoms, Digestive Signs and Symptoms Protozoan Infections Parasitic Diseases |
Zinc Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013