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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Gensavis Pharmaceuticals, LLC
Information provided by (Responsible Party):
Timothy L. McCavit, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01904864
First received: July 17, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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 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

Condition Intervention Phase
Iron Deficiency Anemia
Drug: elemental iron (NovaFerrum®)
Drug: elemental iron (Ferrous Sulfate)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Change in peripheral blood hemoglobin concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment.


Secondary Outcome Measures:
  • Proportion of subjects with complete response to treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with complete response to treatment


Estimated Enrollment: 80
Study Start Date: July 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NovaFerrum®
Subjects randomized to this arm will receive a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, NovaFerrum®, for 12 weeks.
Drug: elemental iron (NovaFerrum®)
Active Comparator: Ferrous Sulfate
Subjects randomized to this arm will receive a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
Drug: elemental iron (Ferrous Sulfate)

  Eligibility

Ages Eligible for Study:   9 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904864

Contacts
Contact: Jackie Powers, MD 214-456-2382 jacquelyn.powers@utsouthwestern.edu
Contact: Leah Adix, CCRP 214-456-2888 leah.adix@childrens.com

Locations
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Gensavis Pharmaceuticals, LLC
Investigators
Principal Investigator: Timothy McCavit, MD U Texas Southwestern
  More Information

No publications provided

Responsible Party: Timothy L. McCavit, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01904864     History of Changes
Other Study ID Numbers: FE15929
Study First Received: July 17, 2013
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
randomized controlled trial
iron medication
Anemia
Hematologic Disease
Anemia, Iron deficiency
anemia, nutritional
ferrous sulfate
NovaFerrum®

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Deficiency Diseases
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014