drugset / Trial / NCT03524651
Ferrous Acetyl-Aspartate Casein Formulation Evaluation Over Ferrous Sulfate in Iron Deficiency Anemia
Phase 4
Completed
60 enrolled
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Amalia Fleming Prefecture General Hospital of Melissia · collabAttikon Hospital · collabG.Gennimatas General Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with iron deficiency anemia (IDA) for the restoration of decreased circulating Hb. The improvement of symptoms of anemia, the restoration of biomarkers of iron deficiency into the normal range and the incidence of GI tract side effects are the study secondary endpoints.
Timeline
- Start
- 2018-05-02
- Primary completion
- 2021-01-08
- Completion
- 2021-01-08
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fe-ASP | Unknown | 800 mg | Oral |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 150 mg | Oral |