Clinically studied • Published in JAMA
NovaFerrum® was evaluated in a randomized, double-blind clinical trial published in JAMA. The study evaluated iron polysaccharide complex (NovaFerrum) in infants and young children with nutritional iron-deficiency anemia.
Clinical Highlights
JAMA • 20177.7→11.1
g/dL mean hemoglobin over 12 weeks*
94%
Successful administration
Once-daily
3 mg/kg elemental iron studied for 12 weeks
The study investigators described both preparations as “effective and well-tolerated.”
Clinical highlights
Children receiving NovaFerrum were significantly more likely to successfully ingest their medication during administration in the study. Successful administration was defined as the child not spitting out the medication.*
94%
NovaFerrum
82%
Ferrous sulfate
Administration
Parents reported significantly less difficulty administering NovaFerrum at weeks 6, 8 and 10.*
More clinical findings
Children receiving NovaFerrum experienced an increase in mean hemoglobin concentration from 7.7 g/dL at baseline to 11.1 g/dL after 12 weeks of treatment.*
Children receiving NovaFerrum experienced improvement in patient-centered signs and symptoms associated with iron-deficiency anemia, including increased energy, decreased pica, and resolution of pallor.*
Adverse effects and tolerability were monitored throughout the 12-week clinical trial. The investigators described the preparations as effective and well-tolerated.*
The published study
Randomized, double-blind clinical trial
Infants and children ages 9-48 months with nutritional iron-deficiency anemia
3 mg/kg of elemental iron once daily for 12 weeks
*Clinical trial context: Results and statements above refer to findings from the published randomized clinical trial. Comparative administration and difficulty-of-administration findings were secondary outcomes. Results should be interpreted within the population, dosing regimen, study design, statistical analyses and limitations described in the full published study.
