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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03055559
Other study ID # Not identified
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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