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

Peking University

Status and phase: Enrolling; Phase 4

Conditions: Peritoneal Dialysis-associated Peritonitis; Vitamin D Deficiency

Treatments: Drug: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT05860270

Vitamin D and Peritonitis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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, 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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176 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day

Treatment:

Drug: Cholecalciferol

Control group

Placebo Comparator group

Description:

Patients will receive placebo, 2 capsules per day.

Treatment:

Drug: Placebo