Badanie kliniczne oceniające wpływ dożylnej suplementacji żelaza w porównaniu z doustną suplementacją żelaza na sprawność fizyczną, jakość życia i funkcje poznawcze u osób starszych z zespołem kruchości, niedoborem żelaza i chorobą sercowo-naczyniową

Kryteria wyłączenia kto nie może wziąć udziału (17)

1. Bed-bound status
2. Body weight below 35 kg
3. Diagnosis of dementia requiring the therapy with anti-dementia drugs
4. Diagnosis of depression requiring the therapy with anti-depres-sive drugs
5. Urgent or elective hospitalisation for whatever reasons (includ-ing percutaneous/surgical procedure requiring hospitalisation) within 4 weeks prior to screening
6. Subject temperature >38°C, or any infection requiring antibi-otic therapy within one week prior to screening
7. Haemoglobin <10 g/dL or >15 g/dL
8. Serum ferritin >400 ng/mL
9. Vitamin B12 and/or folic acid deficiency without effective sup-plementation
10. Vitamin D3 deficiency without effective supplementation
11. Documented liver disease and/or AST or ALT above 3-fold upper laboratory limit or active hepatitis B (HBV) or hepatitis C (HCV) infection, including ongoing antiviral treatment
12. Known hypersensitivity to any of administered preparations or any of their excipients
13. Treatment with erythropoiesis stimulating factors, iv iron ther-apy and/or blood transfusion within 6 months prior to screening
14. Clinical indication that any of these treatments, i.e. erythro-poiesis stimulating factors, i.v./oral iron supplementation and/or blood transfusion, is recommended and should be administered (e.g. severe symptomatic anaemia, chronic kidney disease requir-ing renal replacement therapy)
15. Known active malignancy of any organ system, i.e. clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
16. Participation in a device or drug trial within 3 months prior to screening or 5 half-lives, whichever period is longer, prior to screening
17. Any situation that may prevent the investigations from being performed in accordance with the trial protocol