Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-06 @ 1:03 PM
Study NCT ID:
NCT00944359
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2009-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7680}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2009-07-21', 'studyFirstSubmitQcDate': '2009-07-21', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in length and length-for-age Z-score', 'timeFrame': '12 months'}, {'measure': 'Change in weight and weight-for-age', 'timeFrame': '12 months'}, {'measure': 'Incidence of diarrhea and laboratory-confirmed malaria', 'timeFrame': '12 months'}, {'measure': 'Change in plasma zinc concentration', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of stunting, underweight, and wasting', 'timeFrame': '12 months'}, {'measure': 'Change in hemoglobin and iron status', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['zinc supplementation', 'diarrhea management', 'zinc deficiency', 'malaria'], 'conditions': ['Zinc Deficiency', 'Diarrhea', 'Malaria']}, 'referencesModule': {'references': [{'pmid': '27489011', 'type': 'RESULT', 'citation': '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': '28771493', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '36994923', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nCommunities 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '27 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-27 months of age\n* Plan to remain in study area for 1 year\n\nExclusion Criteria:\n\n* Evidence of congenital abnormalities and chronic infection\n* Severe anemia and severe acute malnutrition\n* Consumption of micronutrient supplementation including zinc'}, 'identificationModule': {'nctId': 'NCT00944359', 'briefTitle': 'Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso', 'orgStudyIdInfo': {'id': '222218'}, 'secondaryIdInfos': [{'id': 'Zinc 7-20'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily preventive Zn; placebo treatment', 'description': '7 mg zinc per day for 12 months and placebo supplement during diarrhea episode', 'interventionNames': ['Dietary Supplement: Daily preventive Zn; placebo treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Therapeutic Zn; daily placebo', 'description': '20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement', 'interventionNames': ['Dietary Supplement: Therapeutic Zn; daily placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Intermittent Zn; placebo treatment', 'description': '10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode', 'interventionNames': ['Dietary Supplement: Intermittent Zn; placebo treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surveillance control group', 'description': 'Surveillance control group will be randomly assigned to intervention groups every 3 months', 'interventionNames': ['Other: Surveillance control group']}, {'type': 'NO_INTERVENTION', 'label': 'Non-intervention', 'description': 'Standard care provided by health system'}], 'interventions': [{'name': 'Daily preventive Zn; placebo treatment', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutriset preventive zinc and therapeutic placebo supplement'], 'description': '7 mg zinc / day and placebo supplement during diarrhea episodes', 'armGroupLabels': ['Daily preventive Zn; placebo treatment']}, {'name': 'Therapeutic Zn; daily placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutriset ZinCfant'], 'description': '20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement', 'armGroupLabels': ['Therapeutic Zn; daily placebo']}, {'name': 'Intermittent Zn; placebo treatment', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutriset zinc supplement'], 'description': '10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes', 'armGroupLabels': ['Intermittent Zn; placebo treatment']}, {'name': 'Surveillance control group', 'type': 'OTHER', 'description': 'Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months', 'armGroupLabels': ['Surveillance control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bobo-Dioulasso', 'country': 'Burkina Faso', 'facility': 'Institut de Recherche en Science de la Sante', 'geoPoint': {'lat': 11.18064, 'lon': -4.29489}}], 'overallOfficials': [{'name': 'Kenneth H Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Polytechnique de Bobo-Dioulasso', 'class': 'OTHER'}, {'name': 'Helen Keller International', 'class': 'OTHER'}, {'name': 'Thrasher Research Fund', 'class': 'OTHER'}, {'name': 'Canadian International Development Agency', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}