NCT00655408

Brief Summary

This work aims at establishing the effectiveness of weekly doses of ferrous sulfate administered by mothers compared with weekly supplements administered directly by healthcare professionals, to reducing anemia prevalence.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2003

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
Last Updated

April 9, 2008

Status Verified

April 1, 2008

Enrollment Period

5 months

First QC Date

April 3, 2008

Last Update Submit

April 3, 2008

Conditions

Anemia

Keywords

InfantsPrevalenceIronDeficiencyTreatment

Outcome Measures

Primary Outcomes (1)

  • Test (serum hemoglobin)

    assessed at the before of the treatment period

Secondary Outcomes (1)

  • Test (serum hemoglobin)

    assessed after 12 weekly with iron supplement

Study Arms (1)

A

ACTIVE COMPARATOR

For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency.This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron. Group 1 administered in the government healthcare clinic. Group 2 administered children's home. The study showed treatment compliance in both groups.

Drug: elemental iron

Interventions

elemental ironDRUG

Iron supplementation.

Also known as: doses of 25 mg of elemental iron
A

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages ranging between six and 24 months old

You may not qualify if:

  • Positive results for the Guthrie test
  • Use of ferrous sulfate supplements
  • Infections process at the time of first consultation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Coutinho GG, Goloni-Bertollo EM, Pavarino-Bertelli EC. Effectiveness of two programs of intermittent ferrous supplementation for treating iron-deficiency anemia in infants: randomized clinical trial. Sao Paulo Med J. 2008 Nov;126(6):314-8. doi: 10.1590/s1516-31802008000600004.

    PMID: 19274317DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Coutinho Geraldo Gaspar Paes Leme, MD

    University Medical School f São Jose do Rio Preto-Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 9, 2008

Study Start

April 1, 2003

Primary Completion

September 1, 2003

Study Completion

January 1, 2004

Last Updated

April 9, 2008

Record last verified: 2008-04