Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya (NICHE)

July 28, 2015 updated by: Centers for Disease Control and Prevention

Diarrhea, Malaria, Anemia, and Helminthiasis Prevention Through Household-based Interventions in Rural Western Kenya: the Nyando Integrated Child Health and Education (NICHE) Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • CDC/Kenya Medical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Product sales and use (coverage)
Time Frame: 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.
Every 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of anemia
Time Frame: Baseline and 12 and 24-month follow-up surveys
Baseline and 12 and 24-month follow-up surveys
Prevalence of iron deficiency
Time Frame: Baseline and 12 and 24-month follow-up surveys
Baseline and 12 and 24-month follow-up surveys

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

Kenya Medical Research Institute
Global Alliance for Improved Nutrition
Safe Water and AIDS Project

Investigators

  • Principal Investigator: Parminder S Suchdev, MD MPH, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (ESTIMATE)

March 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCEZID-5039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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