A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation

January 5, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University
  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
372

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hongli Jiang, Professor
  • Phone Number: 13700280897
  • Email: j92106@sina.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi 'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control group
Placebo
Drug: placebo
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).
Experimental: High-dose vitamin D group
Vitamin D2 softgels 50,000 U/week
Drug: High-dose vitamin D2 softgels
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)
Experimental: Low-dose vitamin D group
low-dose vitamin D group
Drug: low-dose vitamin D2 softgels
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);

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Differences in changes in PTH levels from baseline to 6 months of intervention
Time Frame: baseline，at 6 months intervention
baseline，at 6 months intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
baseline，at 6 months intervention
Change in prevalence of vascular calcification at 6 months of intervention
Time Frame: baseline，at 6 months intervention
We used cardiac ultrasound and lateral abdominal views to look for vascular calcification
baseline，at 6 months intervention
Change in Montreal Cognitive Assessment Scale scores at 6 months of intervention
Time Frame: 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
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
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
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
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
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
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
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
baseline，at 3，6 months intervention
Incidence of fractures at 6 months of intervention
Time Frame: 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
baseline，at 6 months intervention
Incidence of falls at 6 months of intervention
Time Frame: baseline，at 6 months intervention
Ask if the patient has fallen during the intervention, the number of falls and the reasons for them
baseline，at 6 months intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF2022LSK-320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data including baseline characteristics of study population, blood biochemical index and main outcome measures may be made available.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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