The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children
Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children
1 other identifier
interventional
175
1 country
1
Brief Summary
Background: How best to improve iron status among infants in low-income settings is of continued concern in many countries, including Brazil Objective: Design: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with 23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on the correct dosage of iron drops and to feed their children (including whether and how much rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and at 5 mo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedFebruary 10, 2009
February 1, 2009
1.2 years
February 9, 2009
February 9, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Before, the prevalence of ID and anemia in sample were 73.1% and 100%, respectively. At 5-mo, increases occurred in serum ferritin (SF) and hemoglobin (Hb). SF and Hb were observed in both groups. Increases in both measures were seen in the URG group.
Before and after 5 months
Study Arms (2)
iron fortified rice group
EXPERIMENTALiron drop group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- anemia
You may not qualify if:
- non anemic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Minas Gerais - UFMg
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Related Publications (1)
Moretti D, Zimmermann MB, Muthayya S, Thankachan P, Lee TC, Kurpad AV, Hurrell RF. Extruded rice fortified with micronized ground ferric pyrophosphate reduces iron deficiency in Indian schoolchildren: a double-blind randomized controlled trial. Am J Clin Nutr. 2006 Oct;84(4):822-9. doi: 10.1093/ajcn/84.4.822.
PMID: 17023709BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
December 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
February 10, 2009
Record last verified: 2009-02