Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia (BESTIRON)
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 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.
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.
- To compare the adverse effects of treatment for IDA between ferrous sulfate and NovaFerrum®
- 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®
- To compare the adherence to study medication between subjects on ferrous sulfate and NovaFerrum®
- To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional IDA
Iron Deficiency Anemia
Drug: elemental iron (NovaFerrum®)
Drug: elemental iron (Ferrous Sulfate)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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.|
- Change in peripheral blood hemoglobin concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment.
- Proportion of subjects with complete response to treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Proportion of subjects with complete response to treatment
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: NovaFerrum®
Subjects randomized to this arm will receive a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, NovaFerrum®, for 12 weeks.
|Drug: elemental iron (NovaFerrum®)|
Active Comparator: Ferrous Sulfate
Subjects randomized to this arm will receive a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
|Drug: elemental iron (Ferrous Sulfate)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01904864
|Contact: Jackie Powers, MDfirstname.lastname@example.org|
|Contact: Leah Adix, CCRPemail@example.com|
|United States, Texas|
|Children's Medical Center Dallas||Recruiting|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Timothy McCavit, MD||U Texas Southwestern|