Iron-Deficiency Anemia in Infants in Two Weekly Programs (IDA)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs|
- Test (serum hemoglobin) [ Time Frame: assessed at the before of the treatment period ] [ Designated as safety issue: Yes ]
- Test (serum hemoglobin) [ Time Frame: assessed after 12 weekly with iron supplement ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2003|
|Study Completion Date:||January 2004|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
Drug: elemental iron
Other Name: doses of 25 mg of elemental iron
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655408
|Principal Investigator:||Coutinho Geraldo Gaspar Paes Leme, MD||University Medical School f São Jose do Rio Preto-Brazil|