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Recruiting NCT05860270

Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

Phase IV Interventional Peritoneal Dialysis-associated Peritonitis Vitamin D Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cholecalciferol, Placebo.
Who it may be relevant to
Registry conditions: Peritoneal Dialysis-associated Peritonitis, Vitamin D Deficiency. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

176 eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized into two groups, including the intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day. All participants will be followed for 24 months, or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first. The primary outcome is the occurrence of subsequent peritonitis. The study aims to identify whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.

Interventions

  • Drug Cholecalciferol
    Patients in the intervention group will receive oral cholecalciferol 4000U per day.
  • Drug Placebo
    Patients in the control group will receive placebo 2 capsules per day.

Primary outcome measures

  • Hazard Ratio of Subsequent peritonitis [Time frame: 24 months]
Secondary outcome measures (3)
  • rate of Systemic infection [Time frame: 24 months]
  • rate of Technique failure due to peritonitis [Time frame: 24 months]
  • rate of Death or transfer to hemodialysis with reasons other than peritonitis [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT05860270 · Vitamin D and Peritonitis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗