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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
  Purpose

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.


Condition Intervention
Anemia
Iron Deficiency Anemia
Dietary Supplement: iron fortified rice
Dietary Supplement: iron drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

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. [ Time Frame: Before and after 5 months ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iron fortified rice group Dietary Supplement: iron fortified rice
Placebo Comparator: iron drop group Dietary Supplement: iron drops

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • anemia

Exclusion Criteria:

  • non anemic
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00839761

Locations
Brazil
Federal University of Minas Gerais - UFMg
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Sponsors and Collaborators
Federal University of Minas Gerais
Fundação de Amparo à Pesquisa do estado de Minas Gerais
  More Information

Publications:
Responsible Party: Mark Anthony Beinner, Escola de Enfermagem - UFMG
ClinicalTrials.gov Identifier: NCT00839761     History of Changes
Other Study ID Numbers: FDAAA
Study First Received: February 9, 2009
Last Updated: February 9, 2009
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 20, 2014