NCT05860270

Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Peritoneal Dialysis-associated Peritonitis
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Cholecalciferol	Patients in the intervention group will receive oral cholecalciferol 4000U per day.
DRUG	Placebo	Patients in the control group will receive placebo 2 capsules per day.

Timeline

• Start date: 2023-06-15
• Primary completion: 2026-03-31
• Completion: 2026-05-31
• First posted: 2023-05-16
• Last updated: 2024-08-06

Locations

1 site across 1 country: China