1) NovaFerrum now clinically proven to be safe, efficacious, and well tolerated.*
2) NovaFerrum now clinically proven to be superior to Ferrous Sulfate in compliance and adherence.*
Primary Outcomes:
* Efficacy:
- NovaFerrum raised hemoglobin from 7.7 to 11.1 g/dl at goal Results, sentence 2 and Figure 2
* Tolerability:
- More parents reported vomiting in the ferrous sulfate group compared to the NovaFerrum group throughout the trial (looking at Table 4).
* Adverse Effects:
- Less difficulty in giving medication at week 6(P=0.01), week 8(P=0.002), week 10(P=0.03)
Table 4
* Medication Adherence:
- Successful dose administrations: 94% of parents with children receiving NovaFerrum reported that their child did not spit out the medication compared to only 82% of those getting ferrous sulfate. The P = 0.009.
- No missed doses 78% PIC v. 53% FS(P=0.12)
* Compliance
- In Table 4, under “difficulty in giving medication” – again you can see that throughout the trial more parents reported difficulty in giving the medication in the ferrous sulfate group. This was significant in the week 6 and 10-time points.
* QD Dosing
- Efficacy on QD dosing (Discussion Paragraph Six)
* Secondary Outcomes:
* With regard to signs/symptoms of anemia – pallor, energy, pica – both groups had improvement/resolution in similar proportions (Table Two)
* NovaFerrum was clinically proven to be safe, effective and well tolerated with children ages four and under.
* NovaFerrum was clinically proven to be superior to FS in Compliance and Adherence.
* Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial
Jaquelyn M. Powers, MD, MS; George Buchanan, MD; Leah Adix; Son Zhang, PhD; Ang Gao, MS; Timothy L. McCavit, MD, MS
JAMA June 13, 2017 Volume 317, Number 22
