Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

Phase 4RecruitingNCT05860270

Peking University First Hospital176 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

176

Conditions

Peritoneal Dialysis-associated Peritonitis Vitamin D Deficiency

Interventions

CholecalciferolDRUG

Patients in the intervention group will receive oral cholecalciferol 4000U per day.

PlaceboDRUG

Patients in the control group will receive placebo 2 capsules per day.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

rate of Systemic infection

Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.

Time frame: 24 months

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.

Time frame: 24 months

rate of Death or transfer to hemodialysis with reasons other than peritonitis

Death or transfer to hemodialysis with reasons other than peritonitis

Time frame: 24 months

Central Contacts

Jie Dong, Professor

CONTACT

13911841538 jie.dong@bjmu.edu.cn

Zhikai Yang

CONTACT

13671248465 seapollar@126.com

Data from ClinicalTrials.gov

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