Effect of Rice Fortification With Iron on Anemia Among Children

NCT00727545 | Completed Phase 2 DMC

• 1 other identifier: UFRJ-1
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Hemoglobin in crease

Study Arms (1)

1

EXPERIMENTAL

Other: iron bisglycine chelate; Other: placebo

Interventions

iron bisglycine chelate OTHER

1

placebo OTHER

1

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• pre-school children attending public day care centers

You may not qualify if:

• sickle cell anemia, purpura

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Public day care centers

Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 4, 2008
• Study Start: March 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 6, 2008

Record last verified: 2008-07

Locations

BR (1)