Effect of Rice Fortification With Iron on Anemia Among Children

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727545
• Other study ID #: UFRJ-1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 30, 2008
• Last updated: August 4, 2008
• Start date: March 2006
• Est. completion date: December 2006

Study information

• Verified date: July 2008
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 60 Months

Eligibility

Inclusion Criteria:

• pre-school children attending public day care centers

Exclusion Criteria:

• sickle cell anemia, purpura

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

Other:
• iron bisglycine chelate

• placebo

Locations

Country	Name	City	State
Brazil	Public day care centers	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin in crease