Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
- Conditions
- Vitamin D DeficiencyPeritoneal Dialysis-associated Peritonitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05860270
- Lead Sponsor
- Peking University First Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 176
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Cholecalciferol Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day Control group Placebo Patients will receive placebo, 2 capsules per day.
- Primary Outcome Measures
Name Time Method 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
Name Time Method rate of Systemic infection 24 months Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
rate of Death or transfer to hemodialysis with reasons other than peritonitis 24 months Death or transfer to hemodialysis with reasons other than peritonitis
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.
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China