Trial Protocol GlobiFer - Oral Iron Repletion (TPG)

Gedeon Richter Slovakia, s.r.o.

Status: Completed

Conditions: Iron Deficiency

Treatments: Dietary Supplement: Globifer Forte

Study type: Observational

Funder types: Other

Identifiers

NCT03055559

Not identified

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

60 participants in 1 patient group

Globifer Forte

Treatment:

Dietary Supplement: Globifer Forte