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

NCT05549154 | Unknown

• 1 other identifier: XJTU1AF2022LSK-320
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (1)

• Differences in changes in PTH levels from baseline to 6 months of intervention

  baseline，at 6 months intervention

Secondary Outcomes (15)

• 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

• Trends in changes in 25(OH)D levels from baseline to intervention at 1months、2months、3months、4months、5months、6months

  baseline，at 1，2，3，4，5，6 months intervention

• Incidence of cardiovascular events after 6 months of intervention

  baseline，at 6 months intervention

• Change in prevalence of vascular calcification at 6 months of intervention

  baseline，at 6 months intervention

Study Arms (3)

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

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)

High-dose vitamin D group

low-dose vitamin D2 softgels 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);

Low-dose vitamin D group

placebo 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).

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Patients with chronic kidney disease stage 5d who have been on haemodialysis for 3 months or more
• ng/mL \< 25(OH)D \< 30 ng/mL (liquid phase tandem mass spectrometry).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Hongli Jiang, Professor

CONTACT

13700280897; j92106@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 22, 2022
• Study Start: December 5, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 30, 2023
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)