NCT00839761|CompletedDMC
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
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Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children
Sponsor study identifier
interventional
175
1 country
1
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 2008
Actual (reported)March 2008
Actual (reported)February 9, 2009
Actual (reported)February 10, 2009
Actual (reported)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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Federal University of Minas Gerais - UFMg
Belo Horizonte, Minas Gerais, 30130-100, Brazil
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.
175 participants (actual enrollment reported by the registry).
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil
The Optimization of Bioavailability From Iron Supplements: Study 2
The Optimization of Bioavailability From Iron Supplements: Study 1
Contact the study team to confirm eligibility.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)Last Updated
February 10, 2009
Record last verified: 2009-02
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Source: ClinicalTrials.gov.
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