Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya (NICHE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Safe Water and AIDS Project
Kenya Medical Research Institute
Global Alliance for Improved Nutrition
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01088958
First received: February 26, 2010
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Anemia, Iron-deficiency
Dietary Supplement: Micronutrient powders (Sprinkles)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Product sales and use (coverage) [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 and 24-month follow-up surveys ] [ Designated as safety issue: No ]
  • Prevalence of iron deficiency [ Time Frame: Baseline and 12 and 24-month follow-up surveys ] [ Designated as safety issue: No ]

Enrollment: 7200
Study Start Date: January 2007
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Micronutrient Sprinkles
Sales of Sprinkles in these groups of villages by community vendors
Dietary Supplement: Micronutrient powders (Sprinkles)

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


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.

  Eligibility

Ages Eligible for Study:   6 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088958

Locations
Kenya
CDC/Kenya Medical Research Institute
Kisumu, Kenya
Sponsors and Collaborators
Safe Water and AIDS Project
Kenya Medical Research Institute
Global Alliance for Improved Nutrition
Investigators
Principal Investigator: Parminder S Suchdev, MD MPH Centers for Disease Control and Prevention
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01088958     History of Changes
Other Study ID Numbers: CDC-NCEZID-5039
Study First Received: February 26, 2010
Last Updated: September 24, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Kenya
Child Nutrition Disorders
Social marketing

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014