Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peritoneal Dialysis-associated Peritonitis, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day | Drug: Cholecalciferol<br>* Patients in the intervention group will receive oral cholecalciferol 4000U per day.<br>* Other names: Natural Vitamin D3;|
| Placebo Comparator: Control group<br>Patients will receive placebo, 2 capsules per day. | Drug: Placebo<br>* Patients in the control group will receive placebo 2 capsules per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of Systemic infection | Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc. | 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. | 24 months | 
| rate of Death or transfer to hemodialysis with reasons other than peritonitis | Death or transfer to hemodialysis with reasons other than peritonitis | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal dialysis, Peritonitis, Cholecalciferol