Peritoneal Dialysis-associated Peritonitis, Vitamin D Deficiency
Conditions
Keywords
Peritoneal dialysis, Peritonitis, Cholecalciferol
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.
Interventions
DRUGCholecalciferol
Patients in the intervention group will receive oral cholecalciferol 4000U per day.
DRUGPlacebo
Patients in the control group will receive placebo 2 capsules per day.
Sponsors
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 Medical University
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| rate of Systemic infection | 24 months | Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc. |
| 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. |
| rate of Death or transfer to hemodialysis with reasons other than peritonitis | 24 months | Death or transfer to hemodialysis with reasons other than peritonitis |
Countries
China
Contacts
Primary ContactJie Dong, Professor
Backup ContactZhikai Yang
Outcome results
None listed