Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
NCT ID: NCT00944359
Last Updated: 2018-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7680 participants
INTERVENTIONAL
2010-12-31
2012-02-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Daily preventive Zn; placebo treatment
7 mg zinc per day for 12 months and placebo supplement during diarrhea episode
Daily preventive Zn; placebo treatment
7 mg zinc / day and placebo supplement during diarrhea episodes
Therapeutic Zn; daily placebo
20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement
Therapeutic Zn; daily placebo
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
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
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
Surveillance control group
Surveillance control group will be randomly assigned to intervention groups every 3 months
Surveillance control group
Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
Non-intervention
Standard care provided by health system
No interventions assigned to this group
Interventions
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Daily preventive Zn; placebo treatment
7 mg zinc / day and placebo supplement during diarrhea episodes
Therapeutic Zn; daily placebo
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo 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
Surveillance control group
Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plan to remain in study area for 1 year
Exclusion Criteria
* Severe anemia and severe acute malnutrition
* Consumption of micronutrient supplementation including zinc
6 Months
27 Months
ALL
Yes
Sponsors
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Université Polytechnique de Bobo-Dioulasso
OTHER
Helen Keller International
OTHER
Thrasher Research Fund
OTHER
Canadian International Development Agency
OTHER_GOV
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Kenneth H Brown, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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Institut de Recherche en Science de la Sante
Bobo-Dioulasso, , Burkina Faso
Countries
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References
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Becquey E, Ouedraogo CT, Hess SY, Rouamba N, Prince L, Ouedraogo JB, Vosti SA, Brown KH. Comparison of Preventive and Therapeutic Zinc Supplementation in Young Children in Burkina Faso: A Cluster-Randomized, Community-Based Trial. J Nutr. 2016 Oct;146(10):2058-2066. doi: 10.3945/jn.116.230128. Epub 2016 Aug 3.
Hess SY, Peerson JM, Becquey E, Abbeddou S, Ouedraogo CT, Some JW, Yakes Jimenez E, Ouedraogo JB, Vosti SA, Rouamba N, Brown KH. Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefits of small-quantity lipid-based nutrient supplements (LNS). PLoS One. 2017 Aug 3;12(8):e0181770. doi: 10.1371/journal.pone.0181770. eCollection 2017.
Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
Other Identifiers
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Zinc 7-20
Identifier Type: -
Identifier Source: secondary_id
222218
Identifier Type: -
Identifier Source: org_study_id
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