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

Completed · Phase 4

Conditions studied: Iron Deficiency Anemia

In brief

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

Key facts

Study ID

NCT01904864

Run by

University of Texas Southwestern Medical Center

People needed

80

Starts

2013-07-01

Expected to finish

2015-11-01

Last updated by the study team

2017-12-14

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 9 to < 48 months
• IDA documented by hematologic indices (hemoglobin, MCV, RDW, reticulocyte count, reticulocyte hemoglobin content), serum ferritin, serum iron and total iron binding capacity

You may not qualify if…

• Iron deficiency likely or definitely due to blood loss from the intestine or other sites.
• 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
• History or evidence of intestinal malabsorption
• History of prior intravenous iron therapy
• Major co-morbidity such as a serious chronic medical condition unrelated to iron deficiency apparent on history, physical examination, or laboratory tests
• Other causes of anemia (sickle cell disease, thalassemia, other hemolytic anemia, bone marrow failure, etc.) apparent by history, physical examination, and/or laboratory tests.
• High likelihood of suboptimal adherence by parents with study requirements (previous missed clinic visits)
• Inability to tolerate oral medications
• History of birth at < 30 weeks gestation
• Other medical or social factors at discretion of treating physician

Where it is running

• Children's Medical Center Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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