We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Effect of Rice Fortification With Iron on Anemia Among Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00727545
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : August 6, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Other: iron bisglycine chelate Other: placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Other: iron bisglycine chelate Other: placebo

Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin in crease

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • pre-school children attending public day care centers

Exclusion Criteria:

  • sickle cell anemia, purpura
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727545

Public day care centers
Rio de Janeiro, Brazil
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
More Information

Responsible Party: Ursula Viana Bagni, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00727545     History of Changes
Other Study ID Numbers: UFRJ-1
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs