Iron-Deficiency Anemia in Infants in Two Weekly Programs

Anemia Clinical Trial

— IDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655408
• Other study ID #: FAMERP-001
• Status: Completed
• Phase: N/A
• First received: April 3, 2008
• Last updated: April 3, 2008
• Start date: April 2003
• Est. completion date: January 2004

Study information

• Verified date: April 2008
• Source: Sao Jose do Rio Preto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2004
• Est. primary completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• elemental iron
Iron supplementation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sao Jose do Rio Preto University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test (serum hemoglobin)		assessed at the before of the treatment period	Yes
Secondary	Test (serum hemoglobin)		assessed after 12 weekly with iron supplement	Yes