Actively Recruiting

Phase 4
Age: 19Years +
All Genders
NCT05860270

Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

Led by Peking University First Hospital · Updated on 2024-08-06

176

Participants Needed

1

Research Sites

154 weeks

Total Duration

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Sponsors

P

Peking University First Hospital

Lead Sponsor

P

Peking University Third Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 without clinical uremic symptoms
Not Eligible

You will not qualify if you...

  • Received Vitamin D2/D3 during the previous 1 month
  • 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
  • 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
  • Currently on hemodialysis combined with peritoneal dialysis
  • Pregnant or breastfeeding
  • Assessed by researchers as not suitable for enrollment, including patients who could not regularly follow-up

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

J

Jie Dong, Professor

CONTACT

Z

Zhikai Yang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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