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

Xi'an Jiaotong University

Status: Enrolling

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

Treatments: Drug: low-dose vitamin D2 softgels; Drug: High-dose vitamin D2 softgels; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05549154

XJTU1AF2022LSK-320

Details and patient eligibility

About

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.

Enrollment: 372 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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372 participants in 3 patient groups, including a placebo group

High-dose vitamin D group

Experimental group

Description:

Vitamin D2 softgels 50,000 U/week

Treatment:

Drug: High-dose vitamin D2 softgels

Low-dose vitamin D group

Experimental group

Description:

low-dose vitamin D group

Treatment:

Drug: low-dose vitamin D2 softgels

Control group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo