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

Primary Purpose

Anemia, Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
iron fortified rice
iron drops
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • anemia

Exclusion Criteria:

  • non anemic

Sites / Locations

  • Federal University of Minas Gerais - UFMg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

iron fortified rice group

iron drop group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2009
Last Updated
February 9, 2009
Sponsor
Federal University of Minas Gerais
Collaborators
Fundação de Amparo à Pesquisa do estado de Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT00839761
Brief Title
The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children
Official Title
Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Fundação de Amparo à Pesquisa do estado de Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iron fortified rice group
Arm Type
Experimental
Arm Title
iron drop group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
iron fortified rice
Intervention Type
Dietary Supplement
Intervention Name(s)
iron drops
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: anemia Exclusion Criteria: non anemic
Facility Information:
Facility Name
Federal University of Minas Gerais - UFMg
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17023709
Citation
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.
Results Reference
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The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children

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