NCT00727545

Effect of Rice Fortification With Iron on Anemia Among Children

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 12 Months – 60 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
OTHER	iron bisglycine chelate
OTHER	placebo

Timeline

• Start date: 2006-03-01
• Completion: 2006-12-01
• First posted: 2008-08-04
• Last updated: 2008-08-06

Locations

1 site across 1 country: Brazil