peritoneal dialysis patients with sarcopenia
Conditions
Interventions
Intervention group:Alfacalcidol softgel capsule, 0.5 µg orally once daily for 48 weeks
Control group:Without supplementation of any active vitamin D ingredient for 48 weeks
Sponsors
Ningbo No.2 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years old; 2) Undergoing peritoneal dialysis for at least 1 month; 3) Serum total vitamin D level <30ng/mL; 4) Meet the diagnostic criteria for sarcopenia: decreased skeletal muscle mass + decreased skeletal muscle strength or/and decreased physiological function; 5) Have the ability to understand the nature of the research, voluntarily participate in the research, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Serum calcium >2.52mmol/L or serum phosphorus >1.51mmol/L; 2) Unable to complete bioelectrical impedance tests; 3) Unable to complete grip strength and physiological function assessment tests; 4) In a catabolic state, including but not limited to malignant tumors, HIV infection, or recurrent peritonitis, etc.; 5) Concurrent with critical illness, including but not limited to advanced heart disease, or severe lung disease; 6) Major surgery is planned during the study period; 7) Poor compliance or treatment and follow-up are not expected to be completed; 8) Considering the patient's interests or other reasons, the researchers believe that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with improved skeletal muscle mass or function from baseline at week 48 (composite outcome); | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences between two groups of variation of ASMI, grip strength, 6m walking time and STS time from baseline at week 48; | — |
Countries
China
Contacts
Public ContactLailiang Wang
Ningbo No.2 Hospital
Outcome results
None listed