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| ID | Type | Description | Link |
|---|---|---|---|
| Zinc 7-20 |
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| Name | Class |
|---|---|
| Université Polytechnique de Bobo-Dioulasso | OTHER |
| Helen Keller International | OTHER |
| Thrasher Research Fund | OTHER |
| Canadian International Development Agency |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily preventive Zn; placebo treatment | Experimental | 7 mg zinc per day for 12 months and placebo supplement during diarrhea episode |
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| Therapeutic Zn; daily placebo | Experimental | 20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement |
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| Intermittent Zn; placebo treatment | Experimental | 10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode |
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| Surveillance control group | Active Comparator | Surveillance control group will be randomly assigned to intervention groups every 3 months |
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| Non-intervention | No Intervention | Standard care provided by health system |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily preventive Zn; placebo treatment | Dietary Supplement | 7 mg zinc / day and placebo supplement during diarrhea episodes |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of stunting, underweight, and wasting | 12 months | |
| Change in hemoglobin and iron status | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth H Brown, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recherche en Science de la Sante | Bobo-Dioulasso | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27489011 | Result | 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. | |
| 28771493 | Result |
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| OTHER_GOV |
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| Therapeutic Zn; daily placebo | Dietary Supplement | 20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement |
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| Intermittent Zn; placebo treatment | Dietary 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 |
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| Surveillance control group | Other | Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months |
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| 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. |
| 36994923 | Derived | 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. |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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