Trial Protocol GlobiFer - Oral Iron Repletion

Iron Deficiency Clinical Trial

— TPG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055559
• Other study ID #: Not identified
• Status: Completed
• Phase: N/A
• First received: February 14, 2017
• Last updated: March 13, 2018
• Start date: June 2016
• Est. completion date: May 4, 2017

Study information

• Verified date: March 2018
• Source: Gedeon Richter Slovakia, s.r.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• Globifer Forte

Locations

Country	Name	City	State
Slovakia	Prof. MUDr. Ján Danko, PhD.	Martin

Sponsors (1)

Lead Sponsor	Collaborator
Gedeon Richter Slovakia, s.r.o.

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte		12 weeks