Clinical trial NCT05549154: A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation
Official title: A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease 5D
Secondary Hyperparathyroidism Due to Renal Causes
Vitamin D Deficiency
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 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:

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.

Primary outcomes:
measure: Differences in changes in PTH levels from baseline to 6 months of intervention
timeFrame: baseline，at 6 months intervention
Secondary outcomes:
measure: Differences in changes in PTH levels from baseline to intervention at 1months、2months、3months、4months、5months
timeFrame: baseline，at 1，2，3，4，5 months intervention
measure: Proportion of 25(OH)D >30ng/ml at 3 months of intervention
timeFrame: at 3 months intervention
measure: Trends in changes in 25(OH)D levels from baseline to intervention at 1months、2months、3months、4months、5months、6months
timeFrame: baseline，at 1，2，3，4，5，6 months intervention
measure: Incidence of cardiovascular events after 6 months of intervention
timeFrame: baseline，at 6 months intervention
measure: Change in prevalence of vascular calcification at 6 months of intervention
timeFrame: baseline，at 6 months intervention
measure: Change in Montreal Cognitive Assessment Scale scores at 6 months of intervention
timeFrame: baseline，at 6 months intervention
measure: Trends in blood calcium levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention
timeFrame: baseline，at 1，2，3，4，5，6 months intervention
measure: Trends in blood phosphorus levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention
timeFrame: baseline，at 1，2，3，4，5，6 months intervention
measure: Trends in FGF23 levels at 3 and 6 months of intervention
timeFrame: baseline，at 3，6 months intervention
measure: Trends in Osteocalcin(OC) levels at 3 and 6 months of intervention
timeFrame: baseline，at 3，6 months intervention
measure: Trends in Precollagen type I amino-terminal peptide(PINP) levels at 3 and 6 months of intervention
timeFrame: baseline，at 3，6 months intervention
measure: Trends in β specific collagen degradation products(β-CTX) levels at 3 and 6 months of intervention
timeFrame: baseline，at 3，6 months intervention
measure: Trends in ALP levels at 3 and 6 months of intervention
timeFrame: baseline，at 3，6 months intervention
measure: Incidence of fractures at 6 months of intervention
timeFrame: baseline，at 6 months intervention
measure: Incidence of falls at 6 months of intervention
timeFrame: baseline，at 6 months intervention
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University
state: Shaanxi
Study officials:
References: