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
  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
Endpoint Classification: Pharmacodynamics Study
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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Sao Jose do Rio Preto University

Additional 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
Health Authority: Brazil: National Committee of Ethics in Research

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014