NCT05549154 is a NA clinical trial of High-dose vitamin D2 softgels in Chronic Kidney Disease 5D, sponsored by First Affiliated Hospital Xi'an Jiaotong University.

Who is sponsoring NCT05549154?

NCT05549154 is sponsored by First Affiliated Hospital Xi'an Jiaotong University.

What drugs are being tested in NCT05549154?

Interventions in NCT05549154: High-dose vitamin D2 softgels, low-dose vitamin D2 softgels, placebo.

What condition does NCT05549154 study?

NCT05549154 studies Chronic Kidney Disease 5D, Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Deficiency.

Is NCT05549154 still recruiting?

NCT05549154 is currently status unknown. Last updated 9 January 2023.

Last reviewed 2023-01-09 · How we verify

NCT05549154

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown NA Last updated 9 January 2023

What this trial tests

NA trial testing High-dose vitamin D2 softgels in Chronic Kidney Disease 5D in 372 participants. Status unknown.

Timeline

5 December 2022

Primary endpoint
1 August 2023

30 October 2023

Quick facts

Lead sponsor	First Affiliated Hospital Xi'an Jiaotong University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	372
Start date	5 December 2022
Primary completion	1 August 2023
Estimated completion	30 October 2023
Sites	1 location across China

Drugs / interventions tested

High-dose vitamin D2 softgels — full drug profile →
low-dose vitamin D2 softgels — full drug profile →
placebo

Conditions studied

Chronic Kidney Disease 5D — all drugs for Chronic Kidney Disease 5D →
Secondary Hyperparathyroidism Due to Renal Causes — all drugs for Secondary Hyperparathyroidism Due to Renal Causes →
Vitamin D Deficiency — all drugs for Vitamin D Deficiency →

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Who can join

Adults 18 to 90, any sex, with Chronic Kidney Disease 5D or Secondary Hyperparathyroidism Due to Renal Causes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Chronic Kidney Disease 5D

Currently open trials in the same condition.

NCT07045155 — Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis · Phase 4 · recruiting
NCT05071131 — Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease · NA · recruiting

Other First Affiliated Hospital Xi'an Jiaotong University trials

Trials by the same sponsor.

NCT07389460 — Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND) · Phase 3 · not yet recruiting
NCT07170176 — Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine · NA · recruiting
NCT07168291 — Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Relapsed or Refractory B-cell Lymphoma · EARLY_PHASE1 · not yet recruiting
NCT06775782 — Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis · NA · recruiting
NCT07266467 — Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Dis · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05549154 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital Xi'an Jiaotong University
Last refreshed: 9 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05549154.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing