Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05860270

Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location status: Recruiting

Location contact

Jie Dong

CONTACT

[email protected]

010-83572532

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Patients in the intervention group will receive oral cholecalciferol 4000U per day.

Other names: Natural Vitamin D3

Placebo

Drug

Patients in the control group will receive placebo 2 capsules per day.

Primary outcomes

  1. 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.

Secondary outcomes

  1. rate of Systemic infection

    Time frame: 24 months

    Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Dong, Professor

CONTACT

[email protected]

13911841538

Zhikai Yang

CONTACT

[email protected]

13671248465

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Fangshan District Hospital of Traditional Chinese Medicine
  • Beijing Haidian Hospital
  • Beijing Tsinghua Changgeng Hospital
  • Capital Medical University
  • Peking University International Hospital
  • Peking University People's Hospital
  • Peking University Shenzhen Hospital
  • Peking University Third Hospital

Registry information

Official study title

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

Acronym: VD-PD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 16, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.