A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation
- Conditions
- Secondary Hyperparathyroidism Due to Renal CausesVitamin D DeficiencyChronic Kidney Disease 5D
- Interventions
- Drug: High-dose vitamin D2 softgelsDrug: low-dose vitamin D2 softgelsDrug: placebo
- Registration Number
- NCT05549154
- Brief Summary
1. 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
2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 372
- Age ≥ 18 years.
- Patients with chronic kidney disease stage 5d who have been on haemodialysis for 3 months or more
- 5 ng/mL < 25(OH)D < 30 ng/mL (liquid phase tandem mass spectrometry).
- 130 pg/ml < PTH < 600 pg/ml (electrochemiluminescence method).
- serum phosphorus < 1.78 mmol/L.
- Good compliance with the treatment requirements formulated for the study.
- informed consent from the subject.
- Patients who are prepped for or have undergone renal transplantation or parathyroidectomy.
- taking vitamin D, active vitamin D or analogues and other drugs that may affect 25(OH)D levels within 3 months prior to enrolment
- Treatment affecting PTH results (e.g. cenacaser, etc.) within 3 months prior to enrolment
- Serum calcium > 2.55 mmol/L
- Patients who are pregnant or likely to become pregnant, breastfeeding or planning to become pregnant during the study period
- 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
- 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.
- Known or suspected allergy to any component of the study drug.
- Ongoing participation in other clinical studies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-dose vitamin D group High-dose vitamin D2 softgels Vitamin D2 softgels 50,000 U/week Low-dose vitamin D group low-dose vitamin D2 softgels low-dose vitamin D group Control group placebo Placebo
- Primary Outcome Measures
Name Time Method Differences in changes in PTH levels from baseline to 6 months of intervention baseline，at 6 months intervention
- Secondary Outcome Measures
Name Time Method Differences in changes in PTH levels from baseline to intervention at 1months、2months、3months、4months、5months baseline，at 1，2，3，4，5 months intervention Proportion of 25(OH)D >30ng/ml at 3 months of intervention at 3 months intervention Trends in changes in 25(OH)D levels from baseline to intervention at 1months、2months、3months、4months、5months、6months baseline，at 1，2，3，4，5，6 months intervention Incidence of cardiovascular events after 6 months of intervention baseline，at 6 months intervention Change in prevalence of vascular calcification at 6 months of intervention baseline，at 6 months intervention We used cardiac ultrasound and lateral abdominal views to look for vascular calcification
Change in Montreal Cognitive Assessment Scale scores at 6 months of intervention baseline，at 6 months intervention A total score of 30 on this scale, with a score of ≥26 indicating normal; a score of \<26 indicates the presence of cognitive impairment: 18-26 for mild cognitive impairment, 10-17 for moderate cognitive impairment and \<10 for severe cognitive impairment
Trends in blood calcium levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention baseline，at 1，2，3，4，5，6 months intervention Trends in blood phosphorus levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention baseline，at 1，2，3，4，5，6 months intervention Trends in FGF23 levels at 3 and 6 months of intervention baseline，at 3，6 months intervention Trends in Osteocalcin(OC) levels at 3 and 6 months of intervention baseline，at 3，6 months intervention Trends in Precollagen type I amino-terminal peptide(PINP) levels at 3 and 6 months of intervention baseline，at 3，6 months intervention Trends in β specific collagen degradation products(β-CTX) levels at 3 and 6 months of intervention baseline，at 3，6 months intervention Trends in ALP levels at 3 and 6 months of intervention baseline，at 3，6 months intervention Incidence of fractures at 6 months of intervention baseline，at 6 months intervention Ask if the patient had a fracture during the intervention, the site of the fracture and the type of fracture
Incidence of falls at 6 months of intervention baseline，at 6 months intervention Ask if the patient has fallen during the intervention, the number of falls and the reasons for them
Trial Locations
- Locations (1)
The First Affiliated Hospital of Xi 'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China