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Effect of Rice Fortification With Iron on Anemia Among Children

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00727545
First received: July 30, 2008
Last updated: August 4, 2008
Last verified: July 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   12 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pre-school children attending public day care centers

Exclusion Criteria:

  • sickle cell anemia, purpura
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727545

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

No publications provided

Responsible Party: Ursula Viana Bagni, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00727545     History of Changes
Other Study ID Numbers: UFRJ-1
Study First Received: July 30, 2008
Last Updated: August 4, 2008
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014