Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya

Phase 4

Completed

• Conditions: Anemia, Iron-deficiency
• Interventions: Dietary Supplement: Micronutrient powders (Sprinkles)

• Registration Number: NCT01088958
• Lead Sponsor: Centers for Disease Control and Prevention

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-18
• Primary Completion: 2012-01
• Study Completion: 2014-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micronutrient Sprinkles	Micronutrient powders (Sprinkles)	Sales of Sprinkles in these groups of villages by community vendors

Primary Outcome Measures

Name	Time	Method
Product sales and use (coverage)	Every 2 weeks	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

Name	Time	Method
Prevalence of anemia	Baseline and 12 and 24-month follow-up surveys
Prevalence of iron deficiency	Baseline and 12 and 24-month follow-up surveys

Trial Locations

Locations (1)

CDC/Kenya Medical Research Institute; 🇰🇪 Kisumu, Kenya