RecruitingPhase 4NCT05860270

Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial


Sponsor

Peking University First Hospital

Enrollment

176 participants

Start Date

Jun 15, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

DRUGCholecalciferol

Patients in the intervention group will receive oral cholecalciferol 4000U per day.

DRUGPlacebo

Patients in the control group will receive placebo 2 capsules per day.


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT05860270


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