First Affiliated Hospital Xi'an Jiaotong University
Study content: This is a multicentre, double-blind, randomised controlled study to determine the optimal dose and duration of treatment for the correction of vitamin D insufficiency or deficiency in patients with CKD5d; to investigate whether vitamin D supplementation delays the increase in PTH levels in this group of patients; and to investigate the effects on changes in CKD-MBD-related markers, cardiovascular complications, cognitive function in this group of patients. 2. Study procedure: Based on the inclusion and exclusion of the patients, the study was conducted in accordance with the following criteria Study procedure: Eligible subjects were screened according to inclusion and exclusion criteria and randomly divided into three groups: high-dose vitamin D group, low-dose vitamin D group and control group. Baseline data were collected before the intervention and each group was given different doses of regular vitamin D2 softgels or placebo and followed up. 25(OH)D, PTH, blood Ca, and blood P levels were measured every month; bone metabolism markers, FGF23, and blood counts, liver function, kidney function, lipids, and blood glucose were measured every 3 months; the prevalence of vascular calcification, the incidence of cardiovascular events, and changes in cognitive function scale scores were assessed 6 months after the intervention.
Chronic Kidney Disease 5D
Secondary Hyperparathyroidism Due to Renal Causes
Vitamin D Deficiency
High-dose vitamin D2 softgels
low-dose vitamin D2 softgels
placebo
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 372 participants |
Masking : | Triple |
Primary Purpose : | Prevention |
Official Title : | A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation |
Actual Study Start Date : | December 5, 2022 |
Estimated Primary Completion Date : | August 1, 2023 |
Estimated Study Completion Date : | October 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: High-dose vitamin D group Vitamin D2 Softgels 50,000 IU/week |
Drug: High-dose vitamin D2 softgels |
Experimental: Low-dose vitamin D group low-dose vitamin D group |
Drug: low-dose vitamin D2 softgels |
Placebo Comparator: Control group Placebo |
Drug: placebo |
Ages Eligible for Study: | 18 Years to 90 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China, 710061