Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Leah Adix

Principal Investigator
Jacquelyn Powers

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.

Brief Overview

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

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

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

4. To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional

Participant Eligibility

Inclusion Criteria:

1. Age ≥ 9 to < 48 months

2. IDA documented by hematologic indices (hemoglobin, MCV, RDW, reticulocyte count,
reticulocyte hemoglobin content), serum ferritin, serum iron and total iron binding

Exclusion Criteria:

1. Iron deficiency likely or definitely due to blood loss from the intestine or other

2. Evidence of response to recent/current oral iron therapy, as determined by increase
in hemoglobin by > 1.0 gm/dL and MCV by 5 fL above measurements prior to iron therapy

3. History or evidence of intestinal malabsorption

4. History of prior intravenous iron therapy

5. Major co-morbidity such as a serious chronic medical condition unrelated to iron
deficiency apparent on history, physical examination, or laboratory tests

6. Other causes of anemia (sickle cell disease, thalassemia, other hemolytic anemia,
bone marrow failure, etc.) apparent by history, physical examination, and/or
laboratory tests.

7. High likelihood of suboptimal adherence by parents with study requirements (previous
missed clinic visits)

8. Inability to tolerate oral medications

9. History of birth at < 30 weeks gestation

10. Other medical or social factors at discretion of treating physician