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Effect of Rice Fortification With Iron on Anemia Among Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727545
First Posted: August 4, 2008
Last Update Posted: August 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidade Federal do Rio de Janeiro
  Purpose
This was a double-blind community-based trial, placebo controlled. During 16 weeks, children in the intervention group (GI, n=180) received iron fortified rice, and children in the control group (GC, n=174) received rice with placebo. Anemia was considered present when hemoglobin < 11.0g/dL. Comparison of mean variation on hemoglobin between groups was accessed by using Student's t-test. Hemoglobin concentration improved in both groups, with mean increase of 0.42 g/dL in GI (11.28±1.23 g/dL to 11.75±1.16 g/dL, p < 0.001), and 0.49 g/dL in GC (11.06±1.13 g/dL to 11.51±1.16 g/dL, p < 0.001). Anemia decreased (p < 0.01) in both groups (37.8% to 23.3% in GI and 45.4% to 33.3% in GC), with no differences between them. Hemoglobin increase was significantly higher in children who received total amount of iron ≥ 53.76 mg from fortified rice, compared to those who received less than this cut-off value (0.94 g/dl vs 0.39 g/dl p=0.03). The results suggest that this type of intervention can be useful in anemia control if fortified food intake is adequate.

Condition Intervention Phase
Iron Deficiency Anemia Other: iron bisglycine chelate Other: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Weekly Rice Fortification With Iron on Frequency of Anemia and Hemoglobin Concentration Among Children Attending Public Day Care Centers From Rio de Janeiro

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Hemoglobin in crease

Enrollment: 385
Study Start Date: March 2006
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: 1 Other: iron bisglycine chelate Other: placebo

  Eligibility

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Ages Eligible for Study:   12 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pre-school children attending public day care centers

Exclusion Criteria:

  • sickle cell anemia, purpura
  Contacts and Locations
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): NCT00727545


Locations
Brazil
Public day care centers
Rio de Janeiro, Brazil
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
  More Information

Responsible Party: Ursula Viana Bagni, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00727545     History of Changes
Other Study ID Numbers: UFRJ-1
First Submitted: July 30, 2008
First Posted: August 4, 2008
Last Update Posted: August 6, 2008
Last Verified: July 2008

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