The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children
This study has been completed.
Sponsor:
Federal University of Minas Gerais
Collaborator:
Fundação de Amparo à Pesquisa do Estado de Minas Gerais
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00839761
First received: February 9, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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Purpose
Background: How best to improve iron status among infants in low-income settings is of continued concern in many countries, including Brazil
Objective:
Design: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with 23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on the correct dosage of iron drops and to feed their children (including whether and how much rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and at 5 mo.
| Condition | Intervention |
|---|---|
|
Anemia Iron Deficiency Anemia |
Dietary Supplement: iron fortified rice Dietary Supplement: iron drops |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children |
Resource links provided by NLM:
Further study details as provided by Federal University of Minas Gerais:
Primary Outcome Measures:
- Before, the prevalence of ID and anemia in sample were 73.1% and 100%, respectively. At 5-mo, increases occurred in serum ferritin (SF) and hemoglobin (Hb). SF and Hb were observed in both groups. Increases in both measures were seen in the URG group. [ Time Frame: Before and after 5 months ] [ Designated as safety issue: No ]
| Enrollment: | 175 |
| Study Start Date: | December 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: iron fortified rice group | Dietary Supplement: iron fortified rice |
| Placebo Comparator: iron drop group | Dietary Supplement: iron drops |
Eligibility| Ages Eligible for Study: | 6 Months to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- anemia
Exclusion Criteria:
- non anemic
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839761
Locations
| Brazil | |
| Federal University of Minas Gerais - UFMg | |
| Belo Horizonte, Minas Gerais, Brazil, 30130-100 | |
Sponsors and Collaborators
Federal University of Minas Gerais
Fundação de Amparo à Pesquisa do Estado de Minas Gerais
More Information
Publications:
| Responsible Party: | Mark Anthony Beinner, Escola de Enfermagem - UFMG |
| ClinicalTrials.gov Identifier: | NCT00839761 History of Changes |
| Other Study ID Numbers: | FDAAA |
| Study First Received: | February 9, 2009 |
| Last Updated: | February 9, 2009 |
| Health Authority: | Brazil: Ethics Committee Brazil: Ministry of Health Brazil: National Committee of Ethics in Research |
Additional relevant MeSH terms:
|
Anemia Deficiency Diseases Anemia, Iron-Deficiency Hematologic Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic Iron Metabolism Disorders |
Metabolic Diseases Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013