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Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure

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ClinicalTrials.gov Identifier: NCT00992823
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Anemia Drug: iron supplementation Biological: iron 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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure
Study Start Date : March 2006
Primary Completion Date : February 2007
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Initial and final blood hemoglobin concentration [ Time Frame: 10 months ]

Eligibility Criteria

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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
Contacts and Locations

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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): NCT00992823


Locations
Brazil
Public Day Care Centers
Badi Bassit, Sao Paulo, Brazil
Sponsors and Collaborators
Sao Jose do Rio Preto Medical School
Investigators
Study Director: Patricia M Cury, MDPhD FAMEP
Principal Investigator: Geraldo PL Coutinho, MD Sao Jose do Rio Preto Medical School
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
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by Sao Jose do Rio Preto Medical School:
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