Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Cholecalciferol
DrugPatients in the intervention group will receive oral cholecalciferol 4000U per day.
Placebo
DrugPatients in the control group will receive placebo 2 capsules per day.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Treatment groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
rate of Systemic infection
Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
Time frame
24 months2
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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Peking University Third Hospital
Collaborator
Peking University People's Hospital
Collaborator
Beijing Haidian Hospital
Collaborator
Peking University Shenzhen Hospital
Collaborator
Beijing Fangshan District Hospital of Traditional Chinese Medicine
Collaborator
Peking University International Hospital
Collaborator
Beijing Tsinghua Changgeng Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
Capital Medical University
Collaborator
Source ClinicalTrials.gov