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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
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00727545
Enrollment
385
Registered
2008-08-04
Start date
2006-03-31
Completion date
2006-12-31
Last updated
2008-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

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.

Interventions

OTHERiron bisglycine chelate
OTHERplacebo

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Months to 60 Months
Healthy volunteers
Yes

Inclusion criteria

* pre-school children attending public day care centers

Exclusion criteria

* sickle cell anemia, purpura

Design outcomes

Primary

MeasureTime frame
Hemoglobin in crease

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026