Chronic Kidney Disease 5DNCT05549154
A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation
A study testing High-dose vitamin D2 softgels and low-dose vitamin D2 softgels in people with Chronic Kidney Disease 5D and Secondary Hyperparathyroidism Due to Renal Causes, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease 5D, Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Deficiency
- What is being tested?
- High-dose vitamin D2 softgels and low-dose vitamin D2 softgels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061
Hongli Jiang, 13700280897, j92106@sina.com
About this study
- 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.
- Conditions
- Chronic Kidney Disease 5D, Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Deficiency
- Being tested
- High-dose vitamin D2 softgels, low-dose vitamin D2 softgels, placebo
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose vitamin D2 softgelsDrug
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)
low-dose vitamin D2 softgelsDrug
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);
placeboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| High-dose vitamin D group | Experimental | Vitamin D2 softgels 50,000 U/week Receives: Drug: High-dose vitamin D2 softgels |
| Low-dose vitamin D group | Experimental | low-dose vitamin D group Receives: Drug: low-dose vitamin D2 softgels |
| Control group | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in changes in PTH levels from baseline to 6 months of intervention
Measured: baseline，at 6 months intervention
Secondary outcomes (15)
Differences in changes in PTH levels from baseline to intervention at 1months、2months、3months、4months、5months
Measured: baseline，at 1，2，3，4，5 months intervention
Proportion of 25(OH)D >30ng/ml at 3 months of intervention
Measured: at 3 months intervention
Trends in changes in 25(OH)D levels from baseline to intervention at 1months、2months、3months、4months、5months、6months
Measured: baseline，at 1，2，3，4，5，6 months intervention
Incidence of cardiovascular events after 6 months of intervention
Measured: baseline，at 6 months 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
Measured: baseline，at 6 months intervention
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
Measured: baseline，at 6 months intervention
Trends in blood calcium levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention
Measured: 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
Measured: baseline，at 1，2，3，4，5，6 months intervention
Trends in FGF23 levels at 3 and 6 months of intervention
Measured: baseline，at 3，6 months intervention
Trends in Osteocalcin(OC) levels at 3 and 6 months of intervention
Measured: baseline，at 3，6 months intervention
Trends in Precollagen type I amino-terminal peptide(PINP) levels at 3 and 6 months of intervention
Measured: baseline，at 3，6 months intervention
Trends in β specific collagen degradation products(β-CTX) levels at 3 and 6 months of intervention
Measured: baseline，at 3，6 months intervention
Trends in ALP levels at 3 and 6 months of intervention
Measured: baseline，at 3，6 months 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
Measured: baseline，at 6 months intervention
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
Measured: baseline，at 6 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start5 Dec 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549154
- Sponsor's protocol ID
- XJTU1AF2022LSK-320
- Status last verified
- Jan 2023
- First submitted
- 1 Sep 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data including baseline characteristics of study population, blood biochemical index and main outcome measures may be made available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation
- ClinicalTrials.gov ID
- NCT05549154
- Acronym / sponsor ID
- XJTU1AF2022LSK-320
- Conditions
- Chronic Kidney Disease 5D, Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose vitamin D group | Experimental | Drug: High-dose vitamin D2 softgelsVitamin D2 softgels 50,000 U/week |
| Low-dose vitamin D group | Experimental | Drug: low-dose vitamin D2 softgelslow-dose vitamin D group |
| Control group | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose vitamin D2 softgels5000U/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) | Drug | High-dose vitamin D group |
| low-dose vitamin D2 softgels5000U/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); | Drug | Low-dose vitamin D group |
| placeboplacebo 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). | Drug | Control group |
Primary outcome
Differences in changes in PTH levels from baseline to 6 months of intervention
Time frame: baseline，at 6 months intervention
15 secondary outcomes
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
Proportion of 25(OH)D >30ng/ml at 3 months of intervention
Time frame: at 3 months intervention
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
Incidence of cardiovascular events after 6 months of intervention
Time frame: baseline，at 6 months intervention
Change in prevalence of vascular calcification at 6 months of intervention
Time frame: baseline，at 6 months intervention
Change in Montreal Cognitive Assessment Scale scores at 6 months of intervention
Time frame: baseline，at 6 months intervention
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
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
Trends in FGF23 levels at 3 and 6 months of intervention
Time frame: baseline，at 3，6 months intervention
Trends in Osteocalcin(OC) levels at 3 and 6 months of intervention
Time frame: baseline，at 3，6 months intervention
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
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
Trends in ALP levels at 3 and 6 months of intervention
Time frame: baseline，at 3，6 months intervention
Incidence of fractures at 6 months of intervention
Time frame: baseline，at 6 months intervention
Incidence of falls at 6 months of intervention
Time frame: baseline，at 6 months intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: Yes. The data including baseline characteristics of study population, blood biochemical index and main outcome measures may be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose vitamin D2 softgels and low-dose vitamin D2 softgels in people with Chronic Kidney Disease 5D and Secondary Hyperparathyroidism Due to Renal Causes, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongli Jiang, Professor (13700280897, j92106@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in changes in PTH levels from baseline to 6 months of intervention (time frame: baseline，at 6 months intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.