Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

Vitamin D Deficiency Clinical Trial

— VD-PD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860270
• Other study ID #: Vitamin D and Peritonitis
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: July 2023
• Source: Peking University First Hospital
• Contact: Jie Dong, Professor
• Phone: 13911841538
• Email: jie.dong[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: May 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis-associated Peritonitis
• Peritonitis
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
Patients in the intervention group will receive oral cholecalciferol 4000U per day.
• Placebo
Patients in the control group will receive placebo 2 capsules per day.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (11)

Lead Sponsor

Collaborator

Peking University First Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard Ratio of Subsequent peritonitis	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	rate of Systemic infection	Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.	24 months
Secondary	rate of Technique failure due to peritonitis	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
Secondary	rate of Death or transfer to hemodialysis with reasons other than peritonitis	Death or transfer to hemodialysis with reasons other than peritonitis	24 months