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Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure
This study has been completed.
Sponsor:
Sao Jose do Rio Preto University
Information provided by:
Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:
NCT00992823
First received: October 8, 2009
Last updated: October 14, 2009
Last verified: October 2009
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Purpose
Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the mean life of red blood cells compared to weekly supplementation, in reducing the prevalence of preschool anemia.
Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period. Group 1 received once weekly supplementation and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.
| Condition | Intervention |
|---|---|
| Anemia | Drug: iron supplementation Biological: iron supplementation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure |
Resource links provided by NLM:
Further study details as provided by Sao Jose do Rio Preto University:
Primary Outcome Measures:
- Initial and final blood hemoglobin concentration [ Time Frame: 10 months ]
| Enrollment: | 99 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Group 1:iron weekly supplementation |
Drug: iron supplementation
40 doses of 30 mg of ferrous sulfate during a 10-month intervention period
|
|
Active Comparator: Group 2: cycle supplementation
two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.
|
Biological: iron supplementation
supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.
|
Detailed Description:
The prevalence of anemia after the supplementation regimens reduced from 20.20% to 5.05% (P < 0.0005); the reduction was not significantly different between the two groups (P = 0.35). The mean hemoglobin concentration increased in both groups (Group 1: 0.27 g/dL; P < 0.016 and Group 2: 0.47 g/dL; P < 0.0005) without significant differences between the groups (P = 0.17).
Eligibility| Ages Eligible for Study: | 24 Months to 59 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- The participants of the study were children with ages ranging from 24 to 59 months old that attended four local public day care centers
Exclusion Criteria:
- Presence of infection or reported infections within two weeks prior to the intervention
- Anemia lower than 7.0 g/dL and children taking medications containing ferrous sulfate
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00992823
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992823
Locations
| Brazil | |
| Public Day Care Centers | |
| Badi Bassit, Sao Paulo, Brazil | |
Sponsors and Collaborators
Sao Jose do Rio Preto University
Investigators
| Study Director: | Patricia M Cury, MDPhD | FAMEP |
| Principal Investigator: | Geraldo PL Coutinho, MD | Sao Jose do Rio Preto University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Geraldo Gaspar Paes Leme Coutinho, Sao Jose do Rio Preto University |
| ClinicalTrials.gov Identifier: | NCT00992823 History of Changes |
| Other Study ID Numbers: |
0708/2006 |
| Study First Received: | October 8, 2009 |
| Last Updated: | October 14, 2009 |
Keywords provided by Sao Jose do Rio Preto University:
|
Iron anemia supplementation |
preschoolers prevalence preschoolers children from public day care centers |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases Iron Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017