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Effect of Rice Fortification With Iron on Anemia Among Children

Phase 2
Completed
Conditions
Iron Deficiency Anemia
Interventions
Other: iron bisglycine chelate
Other: placebo
Registration Number
NCT00727545
Lead Sponsor
Universidade Federal do Rio de Janeiro
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
385
Inclusion Criteria
  • pre-school children attending public day care centers
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Exclusion Criteria
  • sickle cell anemia, purpura
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1placebo-
1iron bisglycine chelate-
Primary Outcome Measures
NameTimeMethod
Hemoglobin in crease
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Public day care centers

🇧🇷

Rio de Janeiro, Brazil

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