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Iron-Deficiency Anemia in Infants in Two Weekly Programs

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00655408
Acronym
IDA
Enrollment
130
Registered
2008-04-09
Start date
2003-04-30
Completion date
2004-01-31
Last updated
2008-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Infants, Prevalence, Iron, Deficiency, Treatment

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).

Interventions

Iron supplementation.

Sponsors

Sao Jose do Rio Preto Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Test (serum hemoglobin)assessed at the before of the treatment period

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026