Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya (NICHE)

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 4

Conditions: Anemia, Iron-deficiency

Treatments: Dietary Supplement: Micronutrient powders (Sprinkles)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01088958

CDC-NCEZID-5039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,200 patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,200 participants in 1 patient group

Micronutrient Sprinkles

Experimental group

Description:

Sales of Sprinkles in these groups of villages by community vendors

Treatment:

Dietary Supplement: Micronutrient powders (Sprinkles)