Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-04 @ 5:01 PM
Study NCT ID:
NCT01088958
Status:
COMPLETED
Last Update Posted:
2015-07-30
First Post:
2010-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D015362', 'term': 'Child Nutrition Disorders'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2010-02-26', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Product sales and use (coverage)', 'timeFrame': 'Every 2 weeks', 'description': 'Biweekly household visits of selected cohort take place to assess purchases and use of health products and self reported morbidity outcomes. Household visits started at enrollment and continued throughout 2-year study period.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of anemia', 'timeFrame': 'Baseline and 12 and 24-month follow-up surveys'}, {'measure': 'Prevalence of iron deficiency', 'timeFrame': 'Baseline and 12 and 24-month follow-up surveys'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kenya', 'Child Nutrition Disorders', 'Social marketing'], 'conditions': ['Anemia, Iron-deficiency']}, 'referencesModule': {'references': [{'pmid': '17962803', 'type': 'RESULT', 'citation': 'Centers for Disease Control and Prevention (CDC). Baseline data from the Nyando Integrated Child Health and Education Project--Kenya, 2007. MMWR Morb Mortal Wkly Rep. 2007 Oct 26;56(42):1109-13.'}, {'pmid': '20147465', 'type': 'RESULT', 'citation': 'Suchdev PS, Leeds IL, McFarland DA, Flores R. Is it time to change guidelines for iron supplementation in malarial areas? J Nutr. 2010 Apr;140(4):875-6. doi: 10.3945/jn.109.118638. Epub 2010 Feb 10. No abstract available.'}, {'pmid': '20715601', 'type': 'RESULT', 'citation': 'Suchdev PS, Ruth L, Obure A, Were V, Ochieng C, Ogange L, Owuor M, Ngure F, Quick R, Juliao P, Jung C, Teates K, Cruz K, Jefferds ME. Monitoring the marketing, distribution, and use of Sprinkles micronutrient powders in rural western Kenya. Food Nutr Bull. 2010 Jun;31(2 Suppl):S168-78. doi: 10.1177/15648265100312S209.'}, {'pmid': '36475018', 'type': 'DERIVED', 'citation': 'Davis JN, Williams A, Arnold CD, Rohner F, Wirth JP, Addo Y, Flores-Ayala RC, Oaks BM, Young MF, Suchdev PS, Engle-Stone R. The Relationship Between Ferritin and BMI is Mediated by Inflammation Among Women in Higher-Income Countries, But Not in Most Lower-Income Countries Nor Among Young Children: A Multi-Country Analysis. Curr Dev Nutr. 2022 Sep 9;6(10):nzac139. doi: 10.1093/cdn/nzac139. eCollection 2022 Oct.'}, {'pmid': '26864367', 'type': 'DERIVED', 'citation': 'Suchdev PS, Addo OY, Martorell R, Grant FK, Ruth LJ, Patel MK, Juliao PC, Quick R, Flores-Ayala R. Effects of community-based sales of micronutrient powders on morbidity episodes in preschool children in Western Kenya. Am J Clin Nutr. 2016 Mar;103(3):934-41. doi: 10.3945/ajcn.115.118000. Epub 2016 Feb 10.'}, {'pmid': '22492366', 'type': 'DERIVED', 'citation': 'Suchdev PS, Ruth LJ, Woodruff BA, Mbakaya C, Mandava U, Flores-Ayala R, Jefferds ME, Quick R. Selling Sprinkles micronutrient powder reduces anemia, iron deficiency, and vitamin A deficiency in young children in Western Kenya: a cluster-randomized controlled trial. Am J Clin Nutr. 2012 May;95(5):1223-30. doi: 10.3945/ajcn.111.030072. Epub 2012 Apr 4.'}, {'pmid': '22456661', 'type': 'DERIVED', 'citation': 'Grant FK, Martorell R, Flores-Ayala R, Cole CR, Ruth LJ, Ramakrishnan U, Suchdev PS. Comparison of indicators of iron deficiency in Kenyan children. Am J Clin Nutr. 2012 May;95(5):1231-7. doi: 10.3945/ajcn.111.029900. Epub 2012 Mar 28.'}], 'seeAlsoLinks': [{'url': 'http://www.swapkenya.org/', 'label': 'Implementing NGO'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effectiveness of household-based distribution of evidence-based health products and to measure the health impact of these combined interventions on a population basis.', 'detailedDescription': "Nyanza Province has the highest mortality rates for infants and children under 5 years of age and the highest HIV prevalence rates in Kenya. Burden of disease in western Kenya is further characterized by endemic malaria transmission, diarrheal diseases due to poor access to safe water, and iron deficiency anemia (IDA) in over 60% of children. Access to health interventions in rural Nyanza Province is poor due to limited transportation and communication infrastructure. Delivery of household-based interventions through local institutions offers the potential for increased utilization and improved health outcomes in rural areas. The Centers for Disease Control and Prevention (CDC) in partnership with the Rotary-supported Safe Water and AIDS Project (SWAP), initiated a program in 2007 that combines household, clinic, school, and local commercial distribution approaches to increase access to various evidence-based health products (WaterGuard(TM) and PuR(TM) water disinfectant products, water storage containers, soap, insecticide treated bednets, micronutrient Sprinkles(TM), and albendazole) and measures the health impact of these combined interventions on a population basis.\n\nEvaluation of the intervention will take place over 36 months and will include: 1) baseline and follow-up cross sectional surveys among households in communities visited by SWAP for purchase of products; 2) active household surveillance of diarrhea, febrile illness and Sprinkles(TM) usage; 3) testing of hemoglobin and iron status and anthropometry measurement among children aged 6-35 months; 4) focus groups and targeted interviews to assess the acceptability of health products; and 5) other program evaluation methods.\n\nDuring the baseline and follow-up surveys, demographic information, water, sanitation, hygiene, and health information, dietary intake history, and other data will be collected by questionnaire. A blood specimen collected by fingerstick will be used to test for hemoglobin concentration, malaria parasitemia, and iron status. Follow-up surveys 12 and 24 months after baseline data collection will include collection of similar data to assess the effectiveness of product distribution. Anthropometry will be measured at baseline, 12, and 24 months. Qualitative information on user preferences will be obtained using ongoing focus groups, observations and targeted interviews. The results of these evaluations will be published in reports distributed to SWAP, the Kenyan government, and local NGO's and in peer-reviewed journals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6-36 months at the time of enrollment\n* Live within the study area for the duration of the intervention and follow-up period\n\nExclusion Criteria:\n\n* Unavailable for enrollment on 3 separate household visits\n* Parental refusal to give informed consent'}, 'identificationModule': {'nctId': 'NCT01088958', 'acronym': 'NICHE', 'briefTitle': 'Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Diarrhea, Malaria, Anemia, and Helminthiasis Prevention Through Household-based Interventions in Rural Western Kenya: the Nyando Integrated Child Health and Education (NICHE) Project', 'orgStudyIdInfo': {'id': 'CDC-NCEZID-5039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Micronutrient Sprinkles', 'description': 'Sales of Sprinkles in these groups of villages by community vendors', 'interventionNames': ['Dietary Supplement: Micronutrient powders (Sprinkles)']}], 'interventions': [{'name': 'Micronutrient powders (Sprinkles)', 'type': 'DIETARY_SUPPLEMENT', 'description': "Sprinkles were developed in 1996 by Stanley Zlotkin's research group at the Hospital for Sick Children, University of Toronto as a novel approach for delivering iron and other micronutrients. They come in 1g sachets of dry powder that is then added to any home-prepared semi-solid food, intended for daily consumption by children aged 6-59 months. Formulation includes:\n\nIron (Ferrous fumarate) 12.5 mg, Folic acid 150 µg, Vitamin A 375 µg, Vitamin C 35 mg, Zinc 5 mg, Vitamin B1 0.5 mg, Vitamin B2 0.5 mg, Vitamin B6 0.5 mg, Vitamin B12 0.9 µg, Vitamin D3 5 µg, Vitamin E 6.0 mg, Niacin 6.0 mg, Copper 0.6 mg, Iodine 50 µg", 'armGroupLabels': ['Micronutrient Sprinkles']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'CDC/Kenya Medical Research Institute', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'Parminder S Suchdev, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'Safe Water and AIDS Project', 'class': 'OTHER'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}, {'name': 'Global Alliance for Improved Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}