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

Primary Purpose

Anemia

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

iron supplementation

About this trial

This is an interventional treatment trial for Anemia focused on measuring Iron, anemia, supplementation, preschoolers, prevalence, preschoolers children from public day care centers

Eligibility Criteria

24 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Public Day Care Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1:iron weekly supplementation

Group 2: cycle supplementation

Arm Description

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

Outcomes

Primary Outcome Measures

Initial and final blood hemoglobin concentration

Secondary Outcome Measures

Full Information

NCT ID

NCT00992823

First Posted

October 8, 2009

Last Updated

October 14, 2009

Sponsor

Sao Jose do Rio Preto Medical School

1. Study Identification

Unique Protocol Identification Number

NCT00992823

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sao Jose do Rio Preto Medical School

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

Keywords

Iron, anemia, supplementation, preschoolers, prevalence, preschoolers children from public day care centers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1:iron weekly supplementation

Arm Type

Active Comparator

Arm Title

Group 2: cycle supplementation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

iron supplementation

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

iron supplementation

Intervention Description

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

Primary Outcome Measure Information:

Title

Initial and final blood hemoglobin concentration

Time Frame

10 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia M Cury, MDPhD

Organizational Affiliation

FAMEP

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Geraldo PL Coutinho, MD

Organizational Affiliation

Sao Jose do Rio Preto Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Public Day Care Centers

City

Badi Bassit

State/Province

Sao Paulo

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

23305566

Citation

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.

Results Reference

derived

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

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