Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya (NICHE)
Primary Purpose
Anemia, Iron-deficiency
Status
Completed
Phase
Phase 4
Locations
Kenya
Study Type
Interventional
Intervention
Micronutrient powders (Sprinkles)
Sponsored by
About this trial
This is an interventional prevention trial for Anemia, Iron-deficiency focused on measuring Kenya, Child Nutrition Disorders, Social marketing
Eligibility Criteria
Inclusion Criteria:
- Age 6-36 months at the time of enrollment
- Live within the study area for the duration of the intervention and follow-up period
Exclusion Criteria:
- Unavailable for enrollment on 3 separate household visits
- Parental refusal to give informed consent
Sites / Locations
- CDC/Kenya Medical Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Micronutrient Sprinkles
Arm Description
Sales of Sprinkles in these groups of villages by community vendors
Outcomes
Primary Outcome Measures
Product sales and use (coverage)
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.
Secondary Outcome Measures
Prevalence of anemia
Prevalence of iron deficiency
Full Information
NCT ID
NCT01088958
First Posted
February 26, 2010
Last Updated
July 28, 2015
Sponsor
Centers for Disease Control and Prevention
Collaborators
Safe Water and AIDS Project, Kenya Medical Research Institute, Global Alliance for Improved Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT01088958
Brief Title
Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya
Acronym
NICHE
Official Title
Diarrhea, Malaria, Anemia, and Helminthiasis Prevention Through Household-based Interventions in Rural Western Kenya: the Nyando Integrated Child Health and Education (NICHE) Project
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Safe Water and AIDS Project, Kenya Medical Research Institute, Global Alliance for Improved Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
Evaluation 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.
During 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-deficiency
Keywords
Kenya, Child Nutrition Disorders, Social marketing
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micronutrient Sprinkles
Arm Type
Experimental
Arm Description
Sales of Sprinkles in these groups of villages by community vendors
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient powders (Sprinkles)
Intervention 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:
Iron (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
Primary Outcome Measure Information:
Title
Product sales and use (coverage)
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.
Time Frame
Every 2 weeks
Secondary Outcome Measure Information:
Title
Prevalence of anemia
Time Frame
Baseline and 12 and 24-month follow-up surveys
Title
Prevalence of iron deficiency
Time Frame
Baseline and 12 and 24-month follow-up surveys
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 6-36 months at the time of enrollment
Live within the study area for the duration of the intervention and follow-up period
Exclusion Criteria:
Unavailable for enrollment on 3 separate household visits
Parental refusal to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parminder S Suchdev, MD MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDC/Kenya Medical Research Institute
City
Kisumu
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
17962803
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.
Results Reference
result
PubMed Identifier
20147465
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.
Results Reference
result
PubMed Identifier
20715601
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.
Results Reference
result
PubMed Identifier
26864367
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.
Results Reference
derived
PubMed Identifier
22492366
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.
Results Reference
derived
PubMed Identifier
22456661
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.
Results Reference
derived
Links:
URL
http://www.swapkenya.org/
Description
Implementing NGO
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Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya
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