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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessing the Feasibility and Effectiveness of Distributing Micronutrient Sprinkles Within a Title II Food Aid and Maternal and Child Health Program in Rural Haiti

Conditions
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Anemia

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 20 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Food aid only<br>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)<br>* 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.<br>|
| Experimental: Micronutrient sprinkles + food aid<br>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<br> <br> Behavioral: Education/communication on use of micronutrient sprinkles<br> <br> Dietary Supplement: Fortified food aid (corn-soy blend)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anemia after 2 months of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Infant nutrition, Dietary supplements, Randomized controlled trials, Evaluation studies, Haiti