Back to resultsA Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation
Primary Purpose
Chronic Kidney Disease 5D, Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Deficiency
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-dose vitamin D2 softgels
low-dose vitamin D2 softgels
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease 5D
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The First Affiliated Hospital of Xi 'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High-dose vitamin D group
Low-dose vitamin D group
Control group
Arm Description
Vitamin D2 softgels 50,000 U/week
low-dose vitamin D group
Placebo
Outcomes
Primary Outcome Measures
Differences in changes in PTH levels from baseline to 6 months of intervention
Secondary Outcome Measures
Differences in changes in PTH levels from baseline to intervention at 1months、2months、3months、4months、5months
Proportion of 25(OH)D >30ng/ml at 3 months of intervention
Trends in changes in 25(OH)D levels from baseline to intervention at 1months、2months、3months、4months、5months、6months
Incidence of cardiovascular events after 6 months of intervention
Change in prevalence of vascular calcification at 6 months of 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
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
Trends in blood phosphorus levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention
Trends in FGF23 levels at 3 and 6 months of intervention
Trends in Osteocalcin(OC) levels at 3 and 6 months of intervention
Trends in Precollagen type I amino-terminal peptide(PINP) levels at 3 and 6 months of intervention
Trends in β specific collagen degradation products(β-CTX) levels at 3 and 6 months of intervention
Trends in ALP levels at 3 and 6 months of intervention
Incidence of fractures at 6 months of 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
Ask if the patient has fallen during the intervention, the number of falls and the reasons for them
Full Information
NCT ID
NCT05549154
First Posted
September 1, 2022
Last Updated
January 5, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05549154
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease 5D, Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
372 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-dose vitamin D group
Arm Type
Experimental
Arm Description
Vitamin D2 softgels 50,000 U/week
Arm Title
Low-dose vitamin D group
Arm Type
Experimental
Arm Description
low-dose vitamin D group
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
High-dose vitamin D2 softgels
Intervention Description
5000U/capsule of vitamin D2 soft capsule; High-dose VD group 50,000 U/week, 5 vitamin D2 softgels given twice a week each time; 25(OH)D > 80ng/ml after 3 months of intervention or within 3 months in both groups, changed to 5,000 U/ weekly maintenance until the full 6 months of intervention. To prevent unmasking, the maintenance dose was still given twice weekly (the first time 1 vitamin D2 capsule + 4 placebo capsules were given and the second time 5 placebo capsules were given)
Intervention Type
Drug
Intervention Name(s)
low-dose vitamin D2 softgels
Intervention Description
5000U/capsule of vitamin D2 soft capsule; low-dose VD group 25,000 U/week, 3 vitamin D2 softgels + 2 placebo in the first dose, 2 vitamin D2 softgels + 3 placebo in the second dose, 25(OH)D > 80ng/ml after 3 months of intervention or within 3 months in both groups, changed to 5,000 U/ weekly maintenance until the full 6 months of intervention. To prevent unmasking, the maintenance dose was still given twice weekly (the first time 1 vitamin D2 capsule + 4 placebo capsules were given and the second time 5 placebo capsules were given);
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo was filled with excipients (aniseed ether, refined vegetable oil), and the shape and size were the same as vitamin D2 soft capsule.the control group was given placebo, 5 placebo capsules twice weekly for 6 months of the intervention. The medication was dispensed by a designated person (not the investigator) in advance and independently according to the patient's medication number (only the drug number was provided on the outer packaging).
Primary Outcome Measure Information:
Title
Differences in changes in PTH levels from baseline to 6 months of intervention
Time Frame
baseline，at 6 months intervention
Secondary Outcome Measure Information:
Title
Differences in changes in PTH levels from baseline to intervention at 1months、2months、3months、4months、5months
Time Frame
baseline，at 1，2，3，4，5 months intervention
Title
Proportion of 25(OH)D >30ng/ml at 3 months of intervention
Time Frame
at 3 months intervention
Title
Trends in changes in 25(OH)D levels from baseline to intervention at 1months、2months、3months、4months、5months、6months
Time Frame
baseline，at 1，2，3，4，5，6 months intervention
Title
Incidence of cardiovascular events after 6 months of intervention
Time Frame
baseline，at 6 months intervention
Title
Change in prevalence of vascular calcification at 6 months of intervention
Description
We used cardiac ultrasound and lateral abdominal views to look for vascular calcification
Time Frame
baseline，at 6 months intervention
Title
Change in Montreal Cognitive Assessment Scale scores at 6 months of intervention
Description
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
Time Frame
baseline，at 6 months intervention
Title
Trends in blood calcium levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention
Time Frame
baseline，at 1，2，3，4，5，6 months intervention
Title
Trends in blood phosphorus levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention
Time Frame
baseline，at 1，2，3，4，5，6 months intervention
Title
Trends in FGF23 levels at 3 and 6 months of intervention
Time Frame
baseline，at 3，6 months intervention
Title
Trends in Osteocalcin(OC) levels at 3 and 6 months of intervention
Time Frame
baseline，at 3，6 months intervention
Title
Trends in Precollagen type I amino-terminal peptide(PINP) levels at 3 and 6 months of intervention
Time Frame
baseline，at 3，6 months intervention
Title
Trends in β specific collagen degradation products(β-CTX) levels at 3 and 6 months of intervention
Time Frame
baseline，at 3，6 months intervention
Title
Trends in ALP levels at 3 and 6 months of intervention
Time Frame
baseline，at 3，6 months intervention
Title
Incidence of fractures at 6 months of intervention
Description
Ask if the patient had a fracture during the intervention, the site of the fracture and the type of fracture
Time Frame
baseline，at 6 months intervention
Title
Incidence of falls at 6 months of intervention
Description
Ask if the patient has fallen during the intervention, the number of falls and the reasons for them
Time Frame
baseline，at 6 months intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli Jiang, Professor
Phone
13700280897
Email
j92106@sina.com
Facility Information:
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongli Jiang
Phone
13700280897
Email
j92106@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data including baseline characteristics of study population, blood biochemical index and main outcome measures may be made available.
Learn more about this trial
A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation
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