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

This study has been completed.
Sponsor:
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

October 8, 2009
October 14, 2009
March 2006
February 2007   (final data collection date for primary outcome measure)
Initial and final blood hemoglobin concentration [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00992823 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure
Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
  • Drug: iron supplementation
    40 doses of 30 mg of ferrous sulfate during a 10-month intervention period
  • Biological: iron supplementation
    supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.
  • Active Comparator: Group 1:iron weekly supplementation
    Intervention: Drug: iron supplementation
  • 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.
    Intervention: Biological: iron supplementation
Coutinho GG, Cury PM, Cordeiro JA. Cyclical iron supplementation to reduce anemia among Brazilian preschoolers: a randomized controlled trial. BMC Public Health. 2013 Jan 10;13:21. doi: 10.1186/1471-2458-13-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
July 2008
February 2007   (final data collection date for primary outcome measure)

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
Both
24 Months to 59 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00992823
0708/2006
No
Geraldo Gaspar Paes Leme Coutinho, Sao Jose do Rio Preto University
Sao Jose do Rio Preto University
Not Provided
Study Director: Patricia M Cury, MDPhD FAMEP
Principal Investigator: Geraldo PL Coutinho, MD Sao Jose do Rio Preto University
Sao Jose do Rio Preto University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP