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

Sponsor

Peking University First Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05860270

Collaborator

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

176

Enrollment

Location

Arms

36.7

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Dialysis-associated Peritonitis Vitamin D Deficiency	Drug: Cholecalciferol Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized 1:1 into two groups, includingthe intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day.Eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized 1:1 into two groups, includingthe intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Random number will be generated by statistician who is not involved in the study, and will be masked to all participants, caregivers, investigators and outcomes assessors. Only the drug dispensing personnel will have the decoding table. When an eligible patient is enrolled, he/she will be given a sequential patient number, according to block randomization. Such a patient number indicated its group allocation. The drug dispensing personnel will offer the corresponding drug, however with a random drug number. Serial Serum 25- hydroxy-Vitamin D levels, obtained every three months, will be declassified at the end of the study (24 months after enrollment), or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 10, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Hazard Ratio of Subsequent peritonitis [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 Outcome Measures

rate of Systemic infection [24 months]
Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
rate of Technique failure due to peritonitis [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.
rate of Death or transfer to hemodialysis with reasons other than peritonitis [24 months]
Death or transfer to hemodialysis with reasons other than peritonitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, and without clinical uremic symptoms

Exclusion Criteria:

Receive Vitamin D2/D3 during the previous 12 months;
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