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Trial Protocol GlobiFer - Oral Iron Repletion (TPG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03055559
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : March 14, 2018
Information provided by (Responsible Party):
Gedeon Richter Slovakia, s.r.o.

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

Condition or disease Intervention/treatment
Iron Deficiency Dietary Supplement: Globifer Forte

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Oral Iron Repletion With Globifer Forte® After 12 Weeks of Treatment
Study Start Date : June 2016
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : May 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Group/Cohort Intervention/treatment
Globifer Forte Dietary Supplement: Globifer Forte

Primary Outcome Measures :
  1. Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
female , ≥ 18 ≤ 60 years of age

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03055559

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Prof. MUDr. Ján Danko, PhD.
Martin, Slovakia, 036 01
Sponsors and Collaborators
Gedeon Richter Slovakia, s.r.o.
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Principal Investigator: Ján Danko, PhD. Comenius University's Jessenius Faculty of Medicine
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Responsible Party: Gedeon Richter Slovakia, s.r.o. Identifier: NCT03055559    
Other Study ID Numbers: Not identified
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gedeon Richter Slovakia, s.r.o.:
Iron, Hemoglobin, Feritin, erytrocyty. transferin
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases