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

NCT01904864 | Completed Phase 4 Results

• 1 other identifier: FE15929
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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. 1.To compare the adverse effects of treatment for IDA between ferrous sulfate and NovaFerrum®
2. 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. 3.To compare the adherence to study medication between subjects on ferrous sulfate and NovaFerrum®
4. 4.To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional IDA

Conditions

Iron Deficiency Anemia

Keywords

randomized controlled trial; iron medication; Anemia; Hematologic Disease; Anemia, Iron deficiency; anemia, nutritional; ferrous sulfate; NovaFerrum®

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Concentration Over Time

  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. The primary analysis consists of a linear mixed regression model, which incorporates all subsequent time points into the model and includes treatment and time as covariates and patient random effects to account for correlation among longitudinal measurements from the same patients.

  12 weeks

Study Arms (2)

NovaFerrum®

ACTIVE COMPARATOR

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®)

Ferrous Sulfate

ACTIVE COMPARATOR

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)

Interventions

elemental iron (NovaFerrum®) DRUG

single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, NovaFerrum®, for 12 weeks

Also known as: Generic Name: polysaccharide iron vitamin mineral complex

NovaFerrum®

elemental iron (Ferrous Sulfate) DRUG

single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, Ferrous Sulfate, for 12 weeks

Also known as: Ferrous Sulfate

Ferrous Sulfate

Eligibility Criteria

• Age: 9 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Gensavis Pharmaceuticals, LLC: collaborator

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Powers JM, Buchanan GR, Adix L, Zhang S, Gao A, McCavit TL. Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2297-2304. doi: 10.1001/jama.2017.6846.

  PMID: 28609534 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia; Hematologic Diseases

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Jacquelyn M. Powers, MD
• Organization: Baylor College of Medicine

jacquelyn.powers@bcm.edu

Study Officials

• Patrick Leavey, MD

  U Texas Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 14, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-11

Locations

US (1)