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

Primary Purpose

Anemia

Status
Completed
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
"Sprinkles" containing mulitple micronutrients
Education/communication on use of micronutrient sprinkles
Fortified food aid (corn-soy blend)
Sponsored by
International Food Policy Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Infant nutrition, Dietary supplements, Randomized controlled trials, Evaluation studies, Haiti

Eligibility Criteria

6 Months - 20 Months (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • World Vision-Haiti Regional Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Food aid only

Micronutrient sprinkles + food aid

Arm Description

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.

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

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
August 29, 2012
Sponsor
International Food Policy Research Institute
Collaborators
Cornell University, World Vision, Micronutrient Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT00210405
Brief Title
Feasibility and Effectiveness of Distributing Micronutrient Sprinkles to Reduce Prevalence of Anemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Food Policy Research Institute
Collaborators
Cornell University, World Vision, Micronutrient Initiative

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Infant nutrition, Dietary supplements, Randomized controlled trials, Evaluation studies, Haiti

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Food aid only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Micronutrient sprinkles + food aid
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
"Sprinkles" containing mulitple micronutrients
Intervention Type
Behavioral
Intervention Name(s)
Education/communication on use of micronutrient sprinkles
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortified food aid (corn-soy blend)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of anemia after 2 months of treatment
Secondary Outcome Measure Information:
Title
Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
20 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie T. Ruel, PhD
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Purnima Menon, PhD
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
World Vision-Haiti Regional Office
City
Hinche
Country
Haiti

12. IPD Sharing Statement

Citations:
PubMed Identifier
15646314
Citation
Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
Results Reference
background
PubMed Identifier
12672922
Citation
Zlotkin S, Arthur P, Schauer C, Antwi KY, Yeung G, Piekarz A. Home-fortification with iron and zinc sprinkles or iron sprinkles alone successfully treats anemia in infants and young children. J Nutr. 2003 Apr;133(4):1075-80. doi: 10.1093/jn/133.4.1075.
Results Reference
background
PubMed Identifier
17374671
Citation
Menon P, Ruel MT, Loechl CU, Arimond M, Habicht JP, Pelto G, Michaud L. Micronutrient Sprinkles reduce anemia among 9- to 24-mo-old children when delivered through an integrated health and nutrition program in rural Haiti. J Nutr. 2007 Apr;137(4):1023-30. doi: 10.1093/jn/137.4.1023.
Results Reference
result
PubMed Identifier
19161543
Citation
Loechl CU, Menon P, Arimond M, Ruel MT, Pelto G, Habicht JP, Michaud L. Using programme theory to assess the feasibility of delivering micronutrient Sprinkles through a food-assisted maternal and child health and nutrition programme in rural Haiti. Matern Child Nutr. 2009 Jan;5(1):33-48. doi: 10.1111/j.1740-8709.2008.00154.x.
Results Reference
result
Links:
URL
http://sghi.org/about_sprinkles/index.html
Description
Sprinkles Global Health Initiative

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

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