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Sponsored by: |
Sao Jose do Rio Preto University |
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Information provided by: | Sao Jose do Rio Preto University |
ClinicalTrials.gov Identifier: | NCT00655408 |
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.
Condition | Intervention |
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Anemia |
Drug: elemental iron |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs |
Enrollment: | 130 |
Study Start Date: | April 2003 |
Study Completion Date: | January 2004 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
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
Iron supplementation.
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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).
Ages Eligible for Study: | 6 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sao Jose do Rio Preto Medical School ( Sao Jose do Rio Preto Medical School ) |
Study ID Numbers: | FAMERP-001 |
Study First Received: | April 3, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00655408 History of Changes |
Health Authority: | Brazil: Ministry of Health |
Infants Prevalence Iron Deficiency Treatment |
Metabolic Diseases Hematologic Diseases Anemia Trace Elements Micronutrients |
Iron Metabolism Disorders Iron Metabolic Disorder Anemia, Iron-Deficiency |
Metabolic Diseases Hematologic Diseases Growth Substances Physiological Effects of Drugs Anemia, Hypochromic Anemia |
Trace Elements Micronutrients Iron Metabolism Disorders Iron Pharmacologic Actions Anemia, Iron-Deficiency |