Trial Protocol GlobiFer - Oral Iron Repletion
Completed
- Conditions
- Iron Deficiency
- Interventions
- Dietary Supplement: Globifer Forte
- Registration Number
- NCT03055559
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
- ≥ 18 ≤ 60 years of age
- Signed written informed consent
- Hb ≥ 8 ≤ 10g/dl for
- Female
Exclusion Criteria
- History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
- Known hypersensitivity to oral iron preparations.
- Diseases, which an iron supplementation is not allowed or contraindicated.
- Patients on current oral or intravenous iron supplementation
- History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
- Patients who have had iron supplementation within the last 30 days.
- Other reasons which in the investigator's judgment argue against inclusion of the patient into the trial.
- Inability to comprehend study protocol
- Participation in another clinical trial (currently or within the last 30 days)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Globifer Forte Globifer Forte -
- Primary Outcome Measures
Name Time Method Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Prof. MUDr. Ján Danko, PhD.
🇸🇰Martin, Slovakia