Clinical trial NCT00210405: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
Infant nutrition
Dietary supplements
Randomized controlled trials
Evaluation studies
Haiti
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Cornell University
name: World Vision
name: Micronutrient Initiative
First posted: 2005-09-21
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Prevalence of anemia after 2 months of treatment
Secondary outcomes:
measure: Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins
Other outcomes:
Locations:
city: Hinche
country: Haiti
facility: World Vision-Haiti Regional Office
Study officials:
affiliation: International Food Policy Research Institute
name: Marie T. Ruel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Food Policy Research Institute
name: Purnima Menon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.