Chronic Kidney Disease
Conditions
Interventions
High-dose vitamin D group:Vitamin D2 softgels 50,000 U/week
low-dose vitamin D group:Vitamin D2 softgels 25,000 U/week
control group:Placebo
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Patients with chronic kidney disease stage 5d who have been on haemodialysis for 3 months or more; 3. 5 ng/mL < 25(OH)D < 30 ng/mL (liquid phase tandem mass spectrometry); 4. 130 pg/mL < PTH < 600 pg/mL (electrochemiluminescence method); 5. Serum phosphorus < 1.78 mmol/L; 6. Good compliance with the treatment requirements formulated for the study; 7. Informed consent from the subject.
Exclusion criteria
Exclusion criteria: 1. Patients who are prepped for or have undergone renal transplantation or parathyroidectomy; 2. Taking vitamin D, active vitamin D or analogues and other drugs that may affect 25(OH)D levels within 3 months prior to enrolment; 3. Treatment affecting PTH results (e.g. cenacaser, etc.) within 3 months prior to enrolment; 4. Serum calcium > 2.55 mmol/L; 5. Patients who are pregnant or likely to become pregnant, breastfeeding or planning to become pregnant during the study period; 6. Known prior or concomitant serious illness or medical condition such as malignancy, human immunodeficiency virus, severe gastrointestinal or liver disease, intestinal malabsorptive disease, hepatitis or cardiovascular events that may worsen or shorten life expectancy and/or interfere with participation in the study; 7. History of neurological/psychiatric disease, including psychosis or dementia, or any other reason that is unlikely to result in adherence to treatment or follow-up plans; 8. Known or suspected allergy to any component of the study drug; 9. Ongoing participation in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in changes in PTH levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in changes in PTH levels;Proportion of 25(OH)D >30ng/mL;Trends in changes in 25(OH)D levels;Incidence of cardiovascular events;Change in prevalence of vascular calcification;Change in Montreal Cognitive Assessment Scale (MoCA) scores;Trends in blood calcium and phosphorus levels;Trends in FGF23 levels;Incidence of fractures, falls, etc.;Trends in bone metabolism marker levels; | — |
Countries
China
Contacts
Public ContactHongLi Jiang
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed