A Study on Prevention Strategies for CKD-SHPT and Related... | NCT05549154

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

NCT05549154

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Unknown status

Last Update Posted

Jan 9, 2023Actual

Enrollment

372Estimated

Phase

Not Applicable

Conditions

Chronic Kidney Disease 5D
Secondary Hyperparathyroidism Due to Renal Causes
Vitamin D Deficiency

Interventions

High-dose vitamin D2 softgels
low-dose vitamin D2 softgels
placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2022Actual

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Oct 30, 2023Estimated

First Submitted Date

Sep 1, 2022

First Submission Date that Met QC Criteria

Sep 19, 2022

First Posted Date

Sep 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2023

Last Update Posted Date

Jan 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

372Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-dose vitamin D group	Experimental	Vitamin D2 softgels 50,000 U/week	Drug: High-dose vitamin D2 softgels
Low-dose vitamin D group	Experimental	low-dose vitamin D group	Drug: low-dose vitamin D2 softgels
Control group	Placebo Comparator	Placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High-dose vitamin D2 softgels	Drug	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in changes in PTH levels from baseline to 6 months of intervention		baseline，at 6 months intervention

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Hongli Jiang, Professor	Contact	13700280897		j92106@sina.com

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Xi 'an Jiaotong University	Recruiting	Xi'an	Shaanxi	710061	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases