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The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00839761
First received: February 9, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 9, 2009
February 9, 2009
December 2006
March 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: Before and after 5 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
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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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anemia
  • Iron Deficiency Anemia
  • Dietary Supplement: iron fortified rice
  • Dietary Supplement: iron drops
  • Experimental: iron fortified rice group
    Intervention: Dietary Supplement: iron fortified rice
  • Placebo Comparator: iron drop group
    Intervention: Dietary Supplement: iron drops
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • anemia

Exclusion Criteria:

  • non anemic
Both
6 Months to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00839761
FDAAA
Yes
Mark Anthony Beinner, Escola de Enfermagem - UFMG
Federal University of Minas Gerais
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Not Provided
Federal University of Minas Gerais
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP