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

NCT03524651 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-09

No results posted yet for this study

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

Interventions

DRUG

Ferrous Sulfate

Blisters of 10 capsules containing 150 mg of ferrous sulfate.

DRUG

Fe-ASP

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

DRUG

Ferrous Sulfate

Boxes of 10 vials of 15 ml containing inactive ingredients of Omalin.

DRUG

Fe-ASP

Blisters of 10 capsules containing inactive ingredients of Microfer.

Sponsors & Collaborators

  • Attikon Hospital

    collaborator OTHER

  • Amalia Fleming Prefecture General Hospital of Melissia

    collaborator UNKNOWN

  • G.Gennimatas General Hospital

    collaborator OTHER

  • Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

    lead INDUSTRY

Principal Investigators

  • Evangelos Giamarellos-Bourboulis, MD, PhD · Attikon Hospital

  • Nikolaos Tsokos, MD · Amalia Fleming Prefecture General Hospital of Melissia

  • Georgios Adamis, MD · G.Gennimatas General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2021-01-08
Completion
2021-01-08

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03524651 on ClinicalTrials.gov