Phase 4 N=80 Randomized Quadruple-blind Treatment

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

Iron Deficiency Anemia

Bottom Line

View on ClinicalTrials.gov: NCT01904864 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Sep 2017

Primary outcome: Primary: Hemoglobin Concentration Over Time — 7.7; 7.9; 9.3; 10.4 g/dL — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: elemental iron (NovaFerrum®) (Drug); elemental iron (Ferrous Sulfate) (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemoglobin Concentration Over Time	7.7; 7.9; 9.3; 10.4; 10.5; 11.4	<0.001 sig

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

Eligibility Criteria

Inclusion Criteria

Age ≥ 9 to 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

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Data sourced from ClinicalTrials.gov (NCT01904864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.