Effect of Rice Fortification With Iron on Anemia Among Children

This study has been completed.
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
First received: July 30, 2008
Last updated: August 4, 2008
Last verified: July 2008

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


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

Inclusion Criteria:

  • pre-school children attending public day care centers

Exclusion Criteria:

  • sickle cell anemia, purpura
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727545

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:
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014