Effect of Rice Fortification With Iron on Anemia Among Children - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	July 30, 2008
Last Updated Date	August 4, 2008
Start Date ^†	March 2006
Current Primary Outcome Measures ^† (submitted: August 3, 2008)	Hemoglobin in crease
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00727545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Effect of Rice Fortification With Iron on Anemia Among Children
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
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
Study Phase	Phase II, Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^†	Iron Deficiency Anemia
Intervention ^†	Other: iron bisglycine chelate Other: placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	385
Completion Date	December 2006
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria: pre-school children attending public day care centers Exclusion Criteria: sickle cell anemia, purpura
Gender	Both
Ages	12 Months to 60 Months
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	Brazil
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00727545
Responsible Party	Ursula Viana Bagni, Universidade Federal do Rio de Janeiro
Secondary IDs ^††
Study Sponsor ^†	Federal University of Rio de Janeiro
Collaborators ^††
Investigators ^†
Information Provided By	Federal University of Rio de Janeiro
Verification Date	July 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.