Clinical trial NCT05860270: Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
Official title: The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Peritoneal Dialysis-associated Peritonitis
Vitamin D Deficiency
Keywords: Peritoneal dialysis
Peritonitis
Cholecalciferol
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Peking University People's Hospital
name: Beijing Haidian Hospital
name: Peking University Shenzhen Hospital
name: Miyun District of Peking University First Hospital
name: Beijing Fangshan District Hospital of Traditional Chinese Medicine
name: Peking University International Hospital
name: Beijing Tsinghua Changgeng Hospital
name: Beijing Anzhen Hospital, Capital Medicine University
name: Capital Medical University
First posted: 2023-05-16
Enrollment: 176
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hazard Ratio of Subsequent peritonitis
timeFrame: 24 months
Secondary outcomes:
measure: rate of Systemic infection
timeFrame: 24 months
measure: rate of Technique failure due to peritonitis
timeFrame: 24 months
measure: rate of Death or transfer to hemodialysis with reasons other than peritonitis
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Jie Dong
role: PRINCIPAL_INVESTIGATOR
References: