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

NCT ID: NCT00992823

Last Updated: 2009-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1:iron weekly supplementation

Group Type ACTIVE_COMPARATOR

iron supplementation

Intervention Type DRUG

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

Group 2: cycle supplementation

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

Group Type ACTIVE_COMPARATOR

iron supplementation

Intervention Type BIOLOGICAL

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

Interventions

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iron supplementation

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

Intervention Type DRUG

iron supplementation

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

24 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sao Jose do Rio Preto Medical School

OTHER

Sponsor Role lead

Responsible Party

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Sao Jose do Rio Preto University

Principal Investigators

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Patricia M Cury, MDPhD

Role: STUDY_DIRECTOR

FAMEP

Geraldo PL Coutinho, MD

Role: PRINCIPAL_INVESTIGATOR

Sao Jose do Rio Preto Medical School

Locations

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Public Day Care Centers

Badi Bassit, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 23305566 (View on PubMed)

Other Identifiers

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0708/2006

Identifier Type: -

Identifier Source: org_study_id

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