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Clinical Trials/NCT00655408
NCT00655408
Completed
Not Applicable

Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs

Sao Jose do Rio Preto Medical School0 sites130 target enrollmentApril 2003
ConditionsAnemia
Interventionselemental iron

Overview

Phase
Not Applicable
Intervention
elemental iron
Conditions
Anemia
Sponsor
Sao Jose do Rio Preto Medical School
Enrollment
130
Primary Endpoint
Test (serum hemoglobin)
Status
Completed
Last Updated
18 years ago

Overview

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
January 2004
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sao Jose do Rio Preto Medical School

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: elemental iron

Outcomes

Primary Outcomes

Test (serum hemoglobin)

Time Frame: assessed at the before of the treatment period

Secondary Outcomes

  • Test (serum hemoglobin)(assessed after 12 weekly with iron supplement)

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