Clinical trial NCT00655408: Iron-Deficiency Anemia in Infants in Two Weekly Programs
Official title: Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Infants
Prevalence
Iron
Deficiency
Treatment
Lead sponsor: Sao Jose do Rio Preto Medical School
Sponsor class: OTHER
First posted: 2008-04-09
Enrollment: 130
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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).

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

Primary outcomes:
measure: Test (serum hemoglobin)
timeFrame: assessed at the before of the treatment period
Secondary outcomes:
measure: Test (serum hemoglobin)
timeFrame: assessed after 12 weekly with iron supplement
Other outcomes:
Locations:
Study officials:
affiliation: University Medical School f São Jose do Rio Preto-Brazil
name: Coutinho Geraldo Gaspar Paes Leme, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.