Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso
2 other identifiers
interventional
7,680
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJuly 13, 2018
July 1, 2018
1.2 years
July 21, 2009
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Incidence of stunting, underweight, and wasting
12 months
Change in hemoglobin and iron status
12 months
Study Arms (5)
Daily preventive Zn; placebo treatment
EXPERIMENTAL7 mg zinc per day for 12 months and placebo supplement during diarrhea episode
Therapeutic Zn; daily placebo
EXPERIMENTAL20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement
Intermittent Zn; placebo treatment
EXPERIMENTAL10 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
ACTIVE COMPARATORSurveillance control group will be randomly assigned to intervention groups every 3 months
Non-intervention
NO INTERVENTIONStandard care provided by health system
Interventions
7 mg zinc / day and placebo supplement during diarrhea episodes
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes
Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
Eligibility Criteria
You may qualify if:
- months of age
- Plan to remain in study area for 1 year
You may not qualify if:
- Evidence of congenital abnormalities and chronic infection
- Severe anemia and severe acute malnutrition
- Consumption of micronutrient supplementation including zinc
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- Université Polytechnique de Bobo-Dioulassocollaborator
- Helen Keller Internationalcollaborator
- Thrasher Research Fundcollaborator
- Canadian International Development Agencycollaborator
Study Sites (1)
Institut de Recherche en Science de la Sante
Bobo-Dioulasso, Burkina Faso
Related Publications (3)
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.
PMID: 27489011RESULTHess 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.
PMID: 28771493RESULTImdad 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.
PMID: 36994923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth H Brown, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 23, 2009
Study Start
December 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
July 13, 2018
Record last verified: 2018-07