Vitamin D Deficiency Clinical Trial
— VD-PDOfficial title:
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled 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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | Beijing |
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 |
China,
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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