Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
NCT Number: NCT05860270
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in the intervention group will receive oral cholecalciferol 4000U per day.
Other names: Natural Vitamin D3
Patients in the control group will receive placebo 2 capsules per day.
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.
Time frame: 24 months
Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
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.
Time frame: 24 months
Death or transfer to hemodialysis with reasons other than peritonitis
Contact information is provided by the study sponsor or research team.
Jie Dong, Professor
CONTACT
Zhikai Yang
CONTACT
Peking University First Hospital
Other
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial
Acronym: VD-PD
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.
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