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

NCT ID: NCT00839761

Last Updated: 2009-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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iron fortified rice group

Group Type EXPERIMENTAL

iron fortified rice

Intervention Type DIETARY_SUPPLEMENT

iron drop group

Group Type PLACEBO_COMPARATOR

iron drops

Intervention Type DIETARY_SUPPLEMENT

Interventions

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iron fortified rice

Intervention Type DIETARY_SUPPLEMENT

iron drops

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* anemia

Exclusion Criteria

* non anemic
Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Escola de Enfermagem - UFMG

Locations

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Federal University of Minas Gerais - UFMg

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 17023709 (View on PubMed)

Other Identifiers

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FDAAA

Identifier Type: -

Identifier Source: org_study_id

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