Effect of Rice Fortification With Iron on Anemia Among Children
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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 |
- 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 |
Inclusion Criteria:
- pre-school children attending public day care centers
Exclusion Criteria:
- sickle cell anemia, purpura
Contacts and Locations
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 Deficiency Diseases Anemia, Iron-Deficiency Hematologic Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic Iron Metabolism Disorders |
Metabolic Diseases Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013