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

Anemia Clinical Trial

Official title:

Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839761
• Other study ID #: FDAAA
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: February 9, 2009
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: February 2009
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

• anemia

Exclusion Criteria:

• non anemic

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

Dietary Supplement:
• iron fortified rice

• iron drops

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais - UFMg	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No