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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05860270
Other study ID # Vitamin D and Peritonitis
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 15, 2023
Est. completion date May 31, 2026

Study information

Verified date July 2023
Source Peking University First Hospital
Contact Jie Dong, Professor
Phone 13911841538
Email jie.dong@bjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 176
Est. completion date May 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cholecalciferol
Patients in the intervention group will receive oral cholecalciferol 4000U per day.
Placebo
Patients in the control group will receive placebo 2 capsules per day.

Locations

Country Name City State
China Peking University First Hospital Beijing Beijing

Sponsors (11)

Lead Sponsor Collaborator
Peking University First Hospital Beijing Anzhen Hospital, Capital Medicine University, Beijing Fangshan District Hospital of Traditional Chinese Medicine, Beijing Haidian Hospital, Beijing Luhe Hospital, Capital Medicine University, Beijing Tsinghua Changgeng Hospital, Miyun District of Peking University First Hospital, Peking University International Hospital, Peking University People's Hospital, Peking University Shenzhen Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 months
Secondary rate of Systemic infection Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc. 24 months
Secondary 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. 24 months
Secondary rate of Death or transfer to hemodialysis with reasons other than peritonitis Death or transfer to hemodialysis with reasons other than peritonitis 24 months
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