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

Anemia Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT00210405
• Study type: Interventional
• Source: International Food Policy Research Institute
• Status: Completed
• Phase: N/A
• Start date: March 2005
• Completion date: September 2005