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

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ClinicalTrials.gov Identifier: NCT00839761
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : February 10, 2009
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by:
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


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 or disease Intervention/treatment
Anemia Iron Deficiency Anemia Dietary Supplement: iron fortified rice Dietary Supplement: iron drops

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children
Study Start Date : December 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: iron fortified rice group Dietary Supplement: iron fortified rice
Placebo Comparator: iron drop group Dietary Supplement: iron drops

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • anemia

Exclusion Criteria:

  • non anemic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839761

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

Responsible Party: Mark Anthony Beinner, Escola de Enfermagem - UFMG
ClinicalTrials.gov Identifier: NCT00839761     History of Changes
Other Study ID Numbers: FDAAA
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009

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