Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya

Study Overview
=================
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.

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

Conditions
-----------------
Anemia, Iron-deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Micronutrient powders (Sprinkles)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micronutrient Sprinkles<br>Sales of Sprinkles in these groups of villages by community vendors | Dietary Supplement: Micronutrient powders (Sprinkles)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Every 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kenya, Child Nutrition Disorders, Social marketing