Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya

Anemia, Iron-deficiency Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088958
• Other study ID #: CDC-NCEZID-5039
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2010
• Last updated: July 28, 2015
• Start date: January 2007
• Est. completion date: September 2014

Study information

• Verified date: July 2015
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7200
• Est. completion date: September 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 3 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-deficiency

Intervention

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

Locations

Country	Name	City	State
Kenya	CDC/Kenya Medical Research Institute	Kisumu

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Global Alliance for Improved Nutrition, Kenya Medical Research Institute, Safe Water and AIDS Project

Country where clinical trial is conducted

Kenya, 

References & Publications (3)

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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Prevalence of anemia		Baseline and 12 and 24-month follow-up surveys	No
Secondary	Prevalence of iron deficiency		Baseline and 12 and 24-month follow-up surveys	No