Effect of Rice Fortification With Iron on Anemia Among Children

Universidade Federal do Rio de Janeiro

Status and phase: Completed; Phase 3; Phase 2

Conditions: Iron Deficiency Anemia

Treatments: Other: iron bisglycine chelate; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00727545

UFRJ-1

Details and patient eligibility

About

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.

Enrollment: 385 patients

Sex: All

Ages: 12 to 60 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pre-school children attending public day care centers

Exclusion criteria

• sickle cell anemia, purpura

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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385 participants in 1 patient group

1

Experimental group

Treatment:

Other: iron bisglycine chelate

Other: placebo