A single-center, double-blinded, randomized, 12 week, superiority study in infants and young children to compare the efficacy of NovaFerrum(RegisteredTM) versus Ferrous Sulfate in the treatment of nutritional iron deficiency anemia (BESTIRON).

Study ID
STU 032013-067

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Leah Adix
214-456-2888
leah.adix@childrens.com

Principal Investigator
Jacquelyn Powers

Summary

This study is a 12 week randomized, controlled, double-blinded single center superiority trial to compare the efficacy of novaFerrum[RegisteredTM] to ferrous sulfate for the treatment of nutritional iDa in infants and toddlers. Subjects will be referred to the hematology clinic through a variety of sources. if eligible, subjects may enroll on the trial at their first visit (screening/baseline). if enrolled, subjects will complete a daily diary of medication adherence and side effects. Subjects wll receive phone calls at weeks 2, 6 and 10 to encourage adherence and diary completion and to assess side effects. They will have clinic visits at weeks 4, 8 and 12. The week 8 visit as well as the interval phone calls are research only. all else is standard care. at the end of the 12 week study period, subjects will be removed from the iron medication and discharged from clinic, or will continue follow up at the disretion of the treating physician.

Participant Eligibility

1. Age >= 9 to < 48 months
2. IDA documented by hematologic indices (hemoglobin, MCV, reticulocyte hemoglobin content), serum ferritin, and total iron binding capacity (See Protocol Appendix for definition of IDA).