Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis (VD-PD)

August 5, 2024 updated by: Dong Jie, Peking University First Hospital

The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial

This is a multicenter randomized, placebo-controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

176 eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized into two groups, including the intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day. All participants will be followed for 24 months, or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first. The primary outcome is the occurrence of subsequent peritonitis. The study aims to identify whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medically stable and receiving peritoneal dialysis for > 1 month
  • Older than 18 years old
  • Serum 25(OH)D < 30ng/ml
  • Adequate dialysis on evaluation with weekly Kt/V ≥ 1.5, or (revised time: 2023-7-11) without clinical uremic symptoms

Exclusion Criteria:

  • Receive Vitamin D2/D3 during the previous 1 month (revised time: 2023-7-11) ;
  • History of allergic reaction to Cholecalciferol;
  • Current or past malignant disease, active hepatitis or hepatic failure, active autoimmune disease, severe digestive malabsorption or an eating disorder, HIV/AIDS;
  • Acute systemic infection, cardiovascular disease, surgery, or trauma in the last month;
  • A high probability of receiving a kidney transplant or transferring to hemodialysis or drop-out due to socioeconomic causes within 6 months;
  • History of kidney transplant;
  • Hemodialysis combined with peritoneal dialysis currently;
  • Pregnant or breastfeeding;
  • Not suitable enrolled assessed by researchers, including patients who could not regular follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group
Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day
Drug: Cholecalciferol
Patients in the intervention group will receive oral cholecalciferol 4000U per day.
Other Names:
  • Natural Vitamin D3
Placebo Comparator: Control group
Patients will receive placebo, 2 capsules per day.
Drug: Placebo
Patients in the control group will receive placebo 2 capsules per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hazard Ratio of Subsequent peritonitis
Time Frame: 24 months
Risk of a subsequent episode of peritoneal dialysis related peritonitis in the interventional group compared with the control group measured by Hazard Ratio.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of Systemic infection
Time Frame: 24 months
Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
24 months
rate of Technique failure due to peritonitis
Time Frame: 24 months
Including peritonitis associated death (death within 30 days after peritonitis or death during hospitalization due to peritonitis), and transfer to hemodialysis due to uncured peritonitis.
24 months
rate of Death or transfer to hemodialysis with reasons other than peritonitis
Time Frame: 24 months
Death or transfer to hemodialysis with reasons other than peritonitis
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University People's Hospital
Peking University Third Hospital
Peking University International Hospital
Peking University Shenzhen Hospital
Beijing Haidian Hospital
Beijing Tsinghua Changgeng Hospital
Miyun District of Peking University First Hospital
Beijing Fangshan District Hospital of Traditional Chinese Medicine
Beijing Anzhen Hospital, Capital Medicine University
Beijing Luhe Hospital, Capital Medicine University

Investigators

  • Principal Investigator: Jie Dong, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D and Peritonitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe