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Iron-Deficiency Anemia in Infants in Two Weekly Programs

NCT ID: NCT00655408

Last Updated: 2008-04-09

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-01-31

Brief Summary

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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.

Detailed Description

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Some studies have shown satisfactory results in reducing the prevalence of iron deficiency using weekly doses of ferrous sulfate, thereby avoiding these side effects. This deficiency is the most common nutritional disorder during childhood and does not only affect individuals from developing countries but also those from industrialized nations.

For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency. In this age range the prevalence of anemia is at least 20%. However, studies have shown a low rate of compliance by mothers during the recommended period, which may be caused by a lack of care or, more probably, due to the side effects caused by long-term daily ferrous sulfate supplementation, which include nausea, vomiting, diarrhea, staining of teeth and abdominal pain.

This specific study is randomized clinical trial study, achieved in a government healthcare clinic in Sao Jose do Rio Preto, Sao Paulo, Brazil. This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron, either administered in the government healthcare clinic or at the children's home.

The study showed treatment compliance in both groups. Prevalence of anemia for all children was 75% at the beginning of supplementation and 46.3% at the end of the period (p \< 0.0005). Reduction rate for anemic children was 38.3%. Average increases in hemoglobin concentration levels were 0.75 g/dL and 0.65 g/dL, respectively, for home interventions and healthcare clinic administration (p \< 0.00005).

Conditions

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Anemia

Keywords

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Infants Prevalence Iron Deficiency Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

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.

Group Type ACTIVE_COMPARATOR

elemental iron

Intervention Type DRUG

Iron supplementation.

Interventions

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elemental iron

Iron supplementation.

Intervention Type DRUG

Other Intervention Names

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doses of 25 mg of elemental iron

Eligibility Criteria

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Inclusion Criteria

* Ages ranging between six and 24 months old

Exclusion Criteria

* Positive results for the Guthrie test
* Use of ferrous sulfate supplements
* Infections process at the time of first consultation
Minimum Eligible Age

6 Months

Maximum Eligible Age

24 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 Medical School

Principal Investigators

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Coutinho Geraldo Gaspar Paes Leme, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical School f São Jose do Rio Preto-Brazil

References

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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.

Reference Type DERIVED
PMID: 19274317 (View on PubMed)

Other Identifiers

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FAMERP-001

Identifier Type: -

Identifier Source: org_study_id