Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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