Iron Deficiency
Conditions
Keywords
Iron, Hemoglobin, Feritin, erytrocyty. transferin
Brief summary
The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.
Interventions
DIETARY_SUPPLEMENTGlobifer Forte
Sponsors
Gedeon Richter Slovakia, s.r.o.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte | 12 weeks |
Countries
Slovakia
Outcome results
None listed