Feasibility and Effectiveness of Distributing Micronutrient Sprinkles to Reduce Prevalence of Anemia
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| First Received Date ICMJE | September 13, 2005 | ||||||||
| Last Updated Date | August 29, 2012 | ||||||||
| Start Date ICMJE | March 2005 | ||||||||
| Primary Completion Date | September 2005 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Prevalence of anemia after 2 months of treatment | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00210405 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Feasibility and Effectiveness of Distributing Micronutrient Sprinkles to Reduce Prevalence of Anemia | ||||||||
| Official Title ICMJE | Assessing the Feasibility and Effectiveness of Distributing Micronutrient Sprinkles Within a Title II Food Aid and Maternal and Child Health Program in Rural Haiti | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Anemia | ||||||||
| Intervention ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 450 | ||||||||
| Completion Date | September 2005 | ||||||||
| Primary Completion Date | September 2005 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Months to 20 Months | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Haiti | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00210405 | ||||||||
| Other Study ID Numbers ICMJE | 10-0460-INTFOO-01-3-IFPRI | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | International Food Policy Research Institute | ||||||||
| Collaborators ICMJE |
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| Information Provided By | International Food Policy Research Institute | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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