Phase 4
Completed N=80
Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia
Source: ClinicalTrials.gov NCT01904864 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Sep 2017
Primary outcomePrimary: Hemoglobin Concentration Over Time — 7.7; 7.9; 9.3; 10.4 g/dL — p=<0.001
◆ Published Evidence
Highly cited
140citations · ~16 / year
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.
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
Linked Publications
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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.
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 |
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
Data sourced from ClinicalTrials.gov (NCT01904864) and the linked publication. 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. Informational only — not medical advice.