Back to resultsOral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis (VD-PD)
Primary Purpose
Peritoneal Dialysis-associated Peritonitis, Vitamin D Deficiency
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Peritoneal Dialysis-associated Peritonitis focused on measuring Peritoneal dialysis, Peritonitis, Cholecalciferol
Eligibility Criteria
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
Sites / Locations
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day
Patients will receive placebo, 2 capsules per day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
rate of Systemic infection
Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
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.
rate of Death or transfer to hemodialysis with reasons other than peritonitis
Death or transfer to hemodialysis with reasons other than peritonitis
Full Information
NCT ID
NCT05860270
First Posted
April 14, 2023
Last Updated
July 11, 2023
Sponsor
Peking University First Hospital
Collaborators
Peking University Third Hospital, Peking University People's Hospital, Beijing Haidian Hospital, Peking University Shenzhen Hospital, Miyun District of Peking University First Hospital, Beijing Fangshan District Hospital of Traditional Chinese Medicine, Peking University International Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Anzhen Hospital, Capital Medicine University, Beijing Luhe Hospital, Capital Medicine University
1. Study Identification
Unique Protocol Identification Number
NCT05860270
Brief Title
Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
Acronym
VD-PD
Official Title
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
Peking University Third Hospital, Peking University People's Hospital, Beijing Haidian Hospital, Peking University Shenzhen Hospital, Miyun District of Peking University First Hospital, Beijing Fangshan District Hospital of Traditional Chinese Medicine, Peking University International Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Anzhen Hospital, Capital Medicine University, Beijing Luhe Hospital, Capital Medicine University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis-associated Peritonitis, Vitamin D Deficiency
Keywords
Peritoneal dialysis, Peritonitis, Cholecalciferol
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Random number will be generated by statistician who is not involved in the study, and will be masked to all participants, caregivers, investigators and outcomes assessors. Only the drug dispensing personnel will have the decoding table. When an eligible patient is enrolled, he/she will be given a sequential patient number, according to block randomization. Such a patient number indicated its group allocation. The drug dispensing personnel will offer the corresponding drug, however with a random drug number. Serial Serum 25- hydroxy-Vitamin D levels, obtained every three months, will be declassified at the end of the study (24 months after enrollment), or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first.
Allocation
Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo, 2 capsules per day.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Natural Vitamin D3
Intervention Description
Patients in the intervention group will receive oral cholecalciferol 4000U per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients in the control group will receive placebo 2 capsules per day.
Primary Outcome Measure Information:
Title
Hazard Ratio of Subsequent peritonitis
Description
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 Outcome Measure Information:
Title
rate of Systemic infection
Description
Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
Time Frame
24 months
Title
rate of Technique failure due to peritonitis
Description
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
Title
rate of Death or transfer to hemodialysis with reasons other than peritonitis
Description
Death or transfer to hemodialysis with reasons other than peritonitis
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Dong, Professor
Phone
13911841538
Email
jie.dong@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhikai Yang
Phone
13671248465
Email
seapollar@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Dong
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Dong
Phone
010-83572532
Email
jie.dong@bjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
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