Trial Protocol GlobiFer - Oral Iron Repletion (TPG)

March 13, 2018 updated by: Gedeon Richter Slovakia, s.r.o.

Oral Iron Repletion With Globifer Forte® After 12 Weeks of Treatment

The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Martin, Slovakia, 036 01
        • Prof. MUDr. Ján Danko, PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

female , ≥ 18 ≤ 60 years of age

Description

Inclusion Criteria:

  1. ≥ 18 ≤ 60 years of age
  2. Signed written informed consent
  3. Hb ≥ 8 ≤ 10g/dl for
  4. Female

Exclusion Criteria:

  1. History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
  2. Known hypersensitivity to oral iron preparations.
  3. Diseases, which an iron supplementation is not allowed or contraindicated.
  4. Patients on current oral or intravenous iron supplementation
  5. History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
  6. Patients who have had iron supplementation within the last 30 days.
  7. Other reasons which in the investigator's judgment argue against inclusion of the patient into the trial.
  8. Inability to comprehend study protocol
  9. Participation in another clinical trial (currently or within the last 30 days)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Globifer Forte
Dietary supplement: Globifer Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gedeon Richter Slovakia, s.r.o.

Investigators

  • Principal Investigator: Ján Danko, PhD., Comenius University's Jessenius Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

May 4, 2017

Study Completion (Actual)

May 4, 2017

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Not identified

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Iron Deficiency

Clinical Trials on Globifer Forte

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe