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: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Gensavis Pharmaceuticals, LLC
• Treatments: Iron

Criteria

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 capacity

Exclusion Criteria:

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

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