NCT05860270 Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
| NCT ID | NCT05860270 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Peritoneal Dialysis-associated Peritonitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2023-06-15 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 176 participants in total. It began in 2023-06-15 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jie Dong
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT05860270 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Peritoneal Dialysis-associated Peritonitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05860270 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05860270 currently recruiting?
Yes, NCT05860270 is actively recruiting participants. Contact the research team at jie.dong@bjmu.edu.cn for enrollment information.
Where is the NCT05860270 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05860270 clinical trial?
NCT05860270 is sponsored by Peking University First Hospital. The principal investigator is Jie Dong at Peking University First Hospital. The trial plans to enroll 176 participants.