Ferrous Acetyl-Aspartate Casein Formulation Evaluation Over Ferrous Sulfate in Iron Deficiency Anemia

• Status: Completed
• Trial end date: 2021-01-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
• Collaborators: Amalia Fleming Prefecture General Hospital of Melissia; Attikon Hospital; General Hospital of Athens G. Gennimatas; General Hospital of Chalkida
• Treatments: Caseins; Iron; N-Methylaspartate

Criteria

Inclusion Criteria:

• Male or female

• Age equal to or more than 18 years

• Written informed consent provided by the patient

• Hb below 10g/dl, as defined by other trials

• Absolute red blood cell (RBC) count below 4.5 x 106/mm3 for men or 4.0 x 106/mm3 for women

• Mean corpuscular volume (MCV) of RBCs below 80 fl

• Mean corpuscular Hb (MCH) of RBCs below 27 pg

• Total ferritin below 30 ng/ml; this criterion is associated with sensitivity more than 99% for iron deficiency

• In the case of patients with anemia after GI tract hemorrhage, inclusion criteria 6 and 7 DO NOT apply for study inclusion.

Exclusion Criteria:

• Age below 18 years

• Denial to provide written informed consent

• Acute myelogenous or lymphoblastic leukemia

• Multiple myeloma

• Primary or secondary myelodysplastic syndrome

• Planning for start of chemotherapy within the first 30 days after inclusion in the trial

• Planning for start of radiotherapy within the first 30 days after inclusion in the trial

• Intake of erythropoietin

• Planning for start of erythropoietin within the first 30 days after inclusion in the trial

• Intake of chemotherapy the last six months

• Intake of radiotherapy the last six months

• Known hemochromatosis

• Known celiac disease

• Liver cirrhosis of Child-Pugh stage II or III

• Any active overt bleeding

• Pregnancy or lactation