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

Not Applicable

Completed

• Conditions: Anemia; Iron Deficiency Anemia
• Interventions: Dietary Supplement: iron fortified rice; Dietary Supplement: iron drops

• Registration Number: NCT00839761
• Lead Sponsor: Federal University of Minas Gerais

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-02
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Last Update Submitted: 2009-02-09
• Study First Posted: 2009-02-10
• Last Update Posted: 2009-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• anemia

Exclusion Criteria

• non anemic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iron fortified rice group	iron fortified rice	-
iron drop group	iron drops	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of Minas Gerais - UFMg; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil