Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210405
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2005-09-13
Brief Title:
Feasibility and Effectiveness of Distributing Micronutrient Sprinkles to Reduce Prevalence of Anemia
Sponsor:
International Food Policy Research Institute
Organization:
International Food Policy Research Institute
Study Overview
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
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 childrens 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 childrens 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
Micronutrient sprinkles are a novel approach to meeting childrens 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 childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None