At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-center, Double-blinded, Randomized, 12 Week, Superiority Study in Infants and Young Children to Compare the Efficacy of NovaFerrum® Versus Ferrous Sulfate in the Treatment of Nutritional Iron Deficiency Anemia.
In Brief
A Phase 4 clinical trial evaluating elemental iron (NovaFerrum®) and elemental iron (Ferrous Sulfate) for Iron Deficiency Anemia. Completed, enrolled 80 participants across 1 site.
Detailed Summary
This study is a randomized, controlled, double-blinded single center trial to compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency anemia (IDA) in infants and young children. Hypothesis: NovaFerrum® has greater efficacy than ferrous sulfate in increasing hemoglobin concentration during a twelve week course of treatment to subjects with iron deficiency anemia. Primary Aim: To compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional IDA in infants and young children as determined by increase in hemoglobin concentration. Secondary Aims: 1. To compare the adverse effects of treatment for IDA between ferrous sulfate and NovaFerrum® 2. To compare normalization of iron stores as demonstrated by laboratory measures of IDA (ferritin, TIBC, reticulocyte hemoglobin content) between subjects treated with ferrous sulfate or NovaFerrum® 3. To compare the adherence to study medication between subjects on ferrous sulfate and NovaFerrum® 4. To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional IDA
Study Details
Timeline
Interventions
single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, NovaFerrum®, for 12 weeks
single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, Ferrous Sulfate, for 12 weeks