Actively Recruiting
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial
Led by Peking University First Hospital · Updated on 2024-08-06
176
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
P
Peking University Third Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether taking oral vitamin D3 can help reduce the risk of peritoneal dialysis-related peritonitis in patients who have recently recovered from an episode of this infection. This multicenter randomized, placebo-controlled trial focuses on patients undergoing peritoneal dialysis and aims to determine if vitamin D3 supplementation lowers the chances of another peritonitis episode. The study is sponsored by Peking University First Hospital and is in the phase 4 stage. The study will enroll 176 patients who are stable on peritoneal dialysis at least one month after recovery from peritonitis. Participants will be randomly assigned to receive either cholecalciferol (vitamin D3) at a dose of 4000 units daily (2 capsules) or a placebo of 2 capsules daily. They will be followed for up to 24 months or until death, transfer to hemodialysis, loss to follow-up, or withdrawal from the study, whichever occurs first. During the study, researchers will monitor the occurrence of subsequent peritonitis as the primary outcome. Secondary outcomes include rates of systemic infection, technique failure due to peritonitis, and death or transfer to hemodialysis for reasons other than peritonitis. Participants will have regular assessments to track these events. The study uses a randomized, quadruple-blind design to ensure unbiased results and includes continuous monitoring for safety and adherence throughout the 24-month follow-up period.
CONDITIONS
Brief Title
Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically stable and receiving peritoneal dialysis for more than 1 month
- Older than 18 years old
- Serum 25(OH)D less than 30 ng/ml
- Adequate dialysis with weekly Kt/V �5 1.5, or without clinical uremic symptoms
You will not qualify if you...
- Received Vitamin D2 or D3 during the previous 1 month
- 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
- High probability of kidney transplant, transfer to hemodialysis, or dropout due to socioeconomic causes within 6 months
- History of kidney transplant
- Currently receiving hemodialysis combined with peritoneal dialysis
- Pregnant or breastfeeding
- Assessed by researchers as not suitable for enrollment, including inability to follow regular visits
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until death, permanent transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first.
Participants receive daily oral capsules of either vitamin D3 (Cholecalciferol) or placebo to help prevent subsequent peritoneal dialysis-related peritonitis.
Regular visits throughout the treatment period as per study schedule
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
J
Jie Dong, Professor
Z
Zhikai Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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