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CompletedNCT00992823Updated Oct 15, 2009

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

An interventional study of iron supplementation and iron supplementation in Anemia, sponsored by Sao Jose do Rio Preto Medical School. Completed at 1 site in Brazil. Open to participants aged 24 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-15.

Sponsored by Sao Jose do Rio Preto Medical School · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
24 Months to 59 Months
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Anemia

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Keywords

  • Iron
  • anemia
  • supplementation
  • preschoolers
  • prevalence
  • preschoolers children from public day care centers
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 99 is close to the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Sao Jose do Rio Preto Medical School is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Active comparator
    Group 1:iron weekly supplementation

    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.

    Biological: iron supplementation

Interventions

  • Drugiron supplementation

    40 doses of 30 mg of ferrous sulfate during a 10-month intervention period

  • Biologicaliron supplementation

    supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

06

What researchers measure

Primary outcomes

  1. Initial and final blood hemoglobin concentration

    Time frame: 10 months

07

Study locations

1 site
  • Public Day Care Centers
    Badi Bassit, Sao Paulo, Brazil
08

References and documents

Publications

  • 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. PubMed 23305566 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00992823
Lead sponsor
Sao Jose do Rio Preto Medical School
First posted
Oct 9, 2009
Start date
Mar 2006
Primary completion
Feb 2007
Completion
Jul 2008
Last update
Oct 15, 2009

Study contacts

Patricia M Cury, MDPhD
study director · FAMEP
Geraldo PL Coutinho, MD
principal investigator · Sao Jose do Rio Preto Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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