A Phase 4 interventional study of Cholecalciferol and Placebo in Peritoneal Dialysis-associated Peritonitis and Vitamin D Deficiency, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Peking University First Hospital · Phase 4, Interventional, and Prevention
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.
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.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's planned enrollment of 176 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day
Drug: Cholecalciferol
Patients will receive placebo, 2 capsules per day.
Drug: Placebo
Patients in the intervention group will receive oral cholecalciferol 4000U per day.
Also known as: Natural Vitamin D3
Patients in the control group will receive placebo 2 capsules per day.
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 months
rate of Systemic infection
Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
Time frame: 24 months
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 months
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 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Mar 2026, 33 months after the start.
Of 36 non-industry phase 4 interventional studies under Vitamin D Deficiency, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 33 months is above that.
Counting every sponsor, half of 37 studies reached it within 18 months; a quarter within 8 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Cholecalciferol
Peking University First Hospital →