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Sponsored by: |
Federal University of Rio de Janeiro |
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Information provided by: | Federal University of Rio de Janeiro |
ClinicalTrials.gov Identifier: | NCT00727545 |
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 II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 385 |
Study Start Date: | March 2006 |
Study Completion Date: | December 2006 |
Arms | Assigned Interventions |
---|---|
1: Experimental | 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:
Exclusion Criteria:
Responsible Party: | Universidade Federal do Rio de Janeiro ( Ursula Viana Bagni ) |
Study ID Numbers: | UFRJ-1 |
Study First Received: | July 30, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00727545 |
Health Authority: | Brazil: Ethics Committee |
Metabolic Diseases Hematologic Diseases Anemia Iron Metabolism Disorders |
Metabolic disorder Iron Anemia, Iron-Deficiency |
Anemia, Hypochromic |