Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: elemental iron (NovaFerrum®); elemental iron (Ferrous Sulfate)
Intervention description: single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, NovaFerrum®, for 12 weeks; single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, Ferrous Sulfate, for 12 weeks
Intervention MeSH terms: Iron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 9 Months
Maximum age: 48 Months
Healthy volunteers: No
Keywords: randomized controlled trial; iron medication; Anemia; Hematologic Disease; Anemia, Iron deficiency; anemia, nutritional; ferrous sulfate; NovaFerrum®

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:

          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