Feasibility and Effectiveness of Distributing Micronutrient Sprinkles to Reduce Prevalence of Anemia

This study has been completed.
Sponsor:
Collaborators:
Cornell University
World Vision
Micronutrient Initiative
Information provided by:
International Food Policy Research Institute
ClinicalTrials.gov Identifier:
NCT00210405
First received: September 13, 2005
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

The objective of this study is to test the feasibility and effectiveness of distributing micronutrient sprinkles to 6-20 month old children participating in an integrated maternal and child health and nutrition program in rural Haiti. The micronutrient sprinkles have been formulated to prevent or treat anemia in 6-23 month old children. Effectiveness in reducing the prevalence of anemia will be assessed.


Condition Intervention
Anemia
Dietary Supplement: "Sprinkles" containing mulitple micronutrients
Behavioral: Education/communication on use of micronutrient sprinkles
Dietary Supplement: Fortified food aid (corn-soy blend)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing the Feasibility and Effectiveness of Distributing Micronutrient Sprinkles Within a Title II Food Aid and Maternal and Child Health Program in Rural Haiti

Resource links provided by NLM:


Further study details as provided by International Food Policy Research Institute:

Primary Outcome Measures:
  • Prevalence of anemia after 2 months of treatment

Secondary Outcome Measures:
  • Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins

Enrollment: 450
Study Start Date: March 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Food aid only
Children in this arm received fortified food aid commodities supplied through the maternal and child health and nutrition program implemented by World Vision. They received fortified corn-soy blend, which contained iron.
Dietary Supplement: Fortified food aid (corn-soy blend)
This intervention was part of the overall food assisted maternal and child health and nutrition program, and included fortified food aid commodities. Corn soy blend was targeted to the child, while the family also received wheat, lentils and oil.
Experimental: Micronutrient sprinkles + food aid
Children in this arm were enrolled in the food assisted program, and therefore received fortified food aid, as well as 60 sachets of a multiple micronutrient powder (Sprinkles) containing iron, zinc, vitamin A, vitamin C and folic acid
Dietary Supplement: "Sprinkles" containing mulitple micronutrients Behavioral: Education/communication on use of micronutrient sprinkles Dietary Supplement: Fortified food aid (corn-soy blend)
This intervention was part of the overall food assisted maternal and child health and nutrition program, and included fortified food aid commodities. Corn soy blend was targeted to the child, while the family also received wheat, lentils and oil.

Detailed Description:

Anemia is highly prevalent among infants and young children in Haiti and throughout the world. Low intakes of several micronutrients contribute to this problem. It is very difficult to meet the micronutrient needs of infants and young children without substantial amounts of animal-source foods; such foods are not affordable for most families in many poor communities.

Micronutrient sprinkles are a novel approach to meeting children's needs. The sprinkles are packed in sachets containing a daily ration, and are intended to be used in the home and "sprinkled" directly on the children's food. Earlier trials have shown the efficacy of the sprinkles for preventing and treating anemia under controlled conditions.

The current study tests the feasibility and effectiveness when sprinkles are distributed in the programmatic context of a US Title II food aid distribution program, a context that is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study also includes the development and dissemination of educational messages to motivate and enable caregivers to use the sprinkles properly. Based on previous efficacy trials no side-effects are anticipated, but the study also monitors for unanticipated side-effects.

Comparison: Since effectiveness of the sprinkles distributed as part of a take-home ration has not been established, this study employed a randomized controlled design. Randomization occurred at the level of the food distribution point (place where community members gather to receive food rations). Groups were assigned to receive either the take home ration (usual program practice) or the take home ration and the sprinkles. Families receiving only food rations at the control sites will receive sprinkles along with their food ration immediately after data collection is complete. The design was also consistent with the program necessity of a gradual roll-out of this new intervention. The prevalence of anemia among target-age children will be compared between groups that receive a two-month supply of micronutrient sprinkles with their take-home food ration, and those that do not.

  Eligibility

Ages Eligible for Study:   6 Months to 20 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 6-20 months old at time of recruitment
  • Family receives food rations at World Vision-Haiti's Food Distribution Points

Exclusion Criteria:

  • Severe anemia at time of recruitment (hemoglobin <7.0 g/dl)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210405

Locations
Haiti
World Vision-Haiti Regional Office
Hinche, Haiti
Sponsors and Collaborators
International Food Policy Research Institute
Cornell University
World Vision
Micronutrient Initiative
Investigators
Principal Investigator: Marie T. Ruel, PhD International Food Policy Research Institute
Principal Investigator: Purnima Menon, PhD International Food Policy Research Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00210405     History of Changes
Other Study ID Numbers: 10-0460-INTFOO-01-3-IFPRI
Study First Received: September 13, 2005
Last Updated: August 29, 2012
Health Authority: Haiti: Ministry of Health

Keywords provided by International Food Policy Research Institute:
Anemia
Infant nutrition
Dietary supplements
Randomized controlled trials
Evaluation studies
Haiti

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014