NCT00210405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

September 13, 2005

Last Update Submit

August 29, 2012

Conditions

Anemia

Keywords

AnemiaInfant nutritionDietary supplementsRandomized controlled trialsEvaluation studiesHaiti

Outcome Measures

Primary Outcomes (1)

  • Prevalence of anemia after 2 months of treatment

Secondary Outcomes (1)

  • Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins

Study Arms (2)

Food aid only

ACTIVE COMPARATOR

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)

Micronutrient sprinkles + food aid

EXPERIMENTAL

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 micronutrientsBehavioral: Education/communication on use of micronutrient sprinklesDietary Supplement: Fortified food aid (corn-soy blend)

Interventions

"Sprinkles" containing mulitple micronutrientsDIETARY_SUPPLEMENT
Micronutrient sprinkles + food aid
Education/communication on use of micronutrient sprinklesBEHAVIORAL
Micronutrient sprinkles + food aid
Fortified food aid (corn-soy blend)DIETARY_SUPPLEMENT

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.

Food aid onlyMicronutrient sprinkles + food aid

Eligibility Criteria

Age6 Months - 20 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months old at time of recruitment
  • Family receives food rations at World Vision-Haiti's Food Distribution Points

You may not qualify if:

  • Severe anemia at time of recruitment (hemoglobin \<7.0 g/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

World Vision-Haiti Regional Office

Hinche, Haiti

Location

Related Publications (4)

  • 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.

    PMID: 15646314BACKGROUND

  • 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.

    PMID: 12672922BACKGROUND

  • 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.

    PMID: 17374671RESULT

  • 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.

    PMID: 19161543RESULT

Related Links

MeSH Terms

Conditions

Anemia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Marie T. Ruel, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

  • Purnima Menon, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

August 30, 2012

Record last verified: 2012-08

Locations

HA(1)