Status:
COMPLETED
Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Gensavis Pharmaceuticals, LLC
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
9-48 years
Phase:
PHASE4
Brief 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 in...
Detailed Description
Screening/Baseline Assessment (Week 0): * History and Physical Examination: * Detailed history regarding medical disorders predisposing to iron deficiency and diet (breast feeding, iron fortified for...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01904864
Start Date
July 1 2013
End Date
November 1 2015
Last Update
December 14 2017
Active Locations (1)
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1
Children's Medical Center Dallas
Dallas, Texas, United States, 75235