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

NCT01904864 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-12-14

Study results available
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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

Conditions

Interventions

DRUG

elemental iron (NovaFerrum®)

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

DRUG

elemental iron (Ferrous Sulfate)

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

Sponsors & Collaborators

  • Gensavis Pharmaceuticals, LLC

    collaborator UNKNOWN

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Patrick Leavey, MD · U Texas Southwestern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01904864 on ClinicalTrials.gov