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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992823
• Other study ID #: 0708/2006
• Status: Completed
• Phase: N/A
• First received: October 8, 2009
• Last updated: October 14, 2009
• Start date: March 2006
• Est. completion date: July 2008

Study information

• Verified date: October 2009
• Source: Sao Jose do Rio Preto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Months to 59 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Public Day Care Centers	Badi Bassit	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sao Jose do Rio Preto University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial and final blood hemoglobin concentration		10 months	No