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

NCT03524651 | Completed Phase 4

• 1 other identifier: Omalin-01/ACCESS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Iron Deficiency Anemia

Keywords

Iron Deficiency Anemia; Fe-ASP; Casein; Iron protein acetyl aspartate; Restoration of decreased hemoglobin; Ferrous sulfate

Outcome Measures

Primary Outcomes (1)

• Comparative increase of baseline Hb

  The primary study endpoint is the comparative increase of baseline Hb in each study group after the first 4 weeks of treatment. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, the increase of baseline Hb will be adjusted per mg of delivered elemental iron.

  4 weeks

Secondary Outcomes (7)

• Normalization of Hb

  4 weeks and 12 weeks

• Ferritin levels

  4 weeks and 12 weeks

• Absolute reticulocyte count

  1 week, 4 weeks and 12 weeks

• Absolute RBC count, Hb, MCV and MCH

  4 weeks and 12 weeks

• Fatigue symptoms of IDA

  4 weeks and 12 weeks

Study Arms (2)

Ferrous sulfate

ACTIVE COMPARATOR

Patients will take every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elemental iron. Capsules should be taken orally either two hours before meal or two hours after meal. The same patients will take every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-Asp Omalin (Uni-Pharma SA).

Drug: Ferrous Sulfate

Fe-ASP

ACTIVE COMPARATOR

Patients will take every day for 12 weeks two oral placebo capsules. Capsules should be taken orally either two hours before meal or two hours after meal. The same patients will take every day on exactly the same time for 12 weeks two vials of 15 ml volume of the Fe-Asp preparation Omalin (Uni-Pharma SA) delivering 40 mg of elemental iron.

Drug: Fe-ASP

Interventions

Ferrous Sulfate DRUG

Blisters of 10 capsules containing 150 mg of ferrous sulfate.

Also known as: Microfer

Ferrous sulfate

Fe-ASP DRUG

Boxes of 10 vials of 15 ml containing 800 mg of Iron protein acetyl aspartate.

Also known as: Omalin

Fe-ASP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age below 18 years
• Denial to provide written informed consent
• Acute myelogenous or lymphoblastic leukemia
• Multiple myeloma
• Primary or secondary myelodysplastic syndrome
• Intake of erythropoietin
• 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

Sponsors & Collaborators

• Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.: lead
• Attikon Hospital: collaborator
• Amalia Fleming Prefecture General Hospital of Melissia: collaborator
• G.Gennimatas General Hospital: collaborator

Study Sites (3)

General Hospital of Athens G. Gennimatas

Athens, 115 27, Greece

Location

Attikon University Hospital

Haidari/Athens, 12462, Greece

Location

Amalia Fleming Prefecture General Hospital of Melissia

Melíssia, 15127, Greece

Location

Related Publications (1)

• Lazzari F, Carrara M. Overview of clinical trials in the treatment of iron deficiency with iron-acetyl-aspartylated casein. Clin Drug Investig. 2005;25(11):679-89. doi: 10.2165/00044011-200525110-00001.

  PMID: 17532714 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Evangelos Giamarellos-Bourboulis, MD, PhD

  Attikon Hospital

  PRINCIPAL INVESTIGATOR

• Nikolaos Tsokos, MD

  Amalia Fleming Prefecture General Hospital of Melissia

  PRINCIPAL INVESTIGATOR

• Georgios Adamis, MD

  G.Gennimatas General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-dummy, blind, randomized, phase IV clinical trial

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 15, 2018
• Study Start: May 2, 2018
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

GR (3)