Vitamin D supplementation to prevent peritonitis in dialysis patients
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial
This study is testing if taking Vitamin D can help prevent future infections in people on peritoneal dialysis who have recently had peritonitis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05860270 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized, placebo-controlled trial investigates the effects of oral Vitamin D3 supplementation on patients undergoing peritoneal dialysis who have recently recovered from an episode of peritonitis. A total of 176 eligible participants will be randomly assigned to receive either Cholecalciferol (4000 U daily) or a placebo for a duration of 24 months. The primary goal is to determine if Vitamin D3 can reduce the incidence of subsequent peritoneal dialysis-related peritonitis. Participants will be monitored for various outcomes, including the occurrence of further peritonitis episodes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are medically stable, have been on peritoneal dialysis for more than one month, and have low serum Vitamin D levels.
Not a fit: Patients with a history of certain medical conditions, recent infections, or those currently receiving Vitamin D supplementation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of recurrent peritonitis in patients on peritoneal dialysis.
How similar studies have performed: While the specific approach of using Vitamin D supplementation in this context is novel, previous studies have suggested potential benefits of Vitamin D in various health conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jie Dong — Peking University First Hospital
- Study coordinator: Jie Dong, Professor
- Email: jie.dong@bjmu.edu.cn
- Phone: 13911841538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.