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

NCT ID: NCT05549154

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2023-10-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

High-dose vitamin D group

Vitamin D2 softgels 50,000 U/week

Group Type: EXPERIMENTAL

High-dose vitamin D2 softgels

Intervention Type: 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)

Low-dose vitamin D group

low-dose vitamin D group

Group Type: EXPERIMENTAL

low-dose vitamin D2 softgels

Intervention Type: DRUG

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);

Control group

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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).

Interventions

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)

Intervention Type: 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);

Intervention Type: 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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongli Jiang, Professor

Role: CONTACT

j92106@sina.com

13700280897

Facility Contacts

Hongli Jiang

Role: primary

j92106@sina.com

13700280897

Other Identifiers

XJTU1AF2022LSK-320

Identifier Type: -

Identifier Source: org_study_id