Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Vitamin C for Correction of Anemia in Patients Receiving Peritoneal Dialysis

NCT00920413

Anemia Peritoneal Dialysis

COMPLETED PHASE3

Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

NCT02598635

Vitamin D Deficiency Vascular Calcification Renal Insufficiency +1 more

UNKNOWN PHASE4

Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease

NCT00781417

Kidney Disease

COMPLETED NA

Effect of Vitamin D3 Supplementation on Arterial and Bone Remodeling in Chronic Kidney Disease Patients

NCT02999204

Renal Insufficiency, Chronic Vascular Stiffness Bone Diseases, Metabolic

COMPLETED PHASE4

Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease

NCT00796679

Chronic Kidney Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peritoneal Dialysis-associated Peritonitis Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized 1:1 into two groups, includingthe intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Random number will be generated by statistician who is not involved in the study, and will be masked to all participants, caregivers, investigators and outcomes assessors. Only the drug dispensing personnel will have the decoding table. When an eligible patient is enrolled, he/she will be given a sequential patient number, according to block randomization. Such a patient number indicated its group allocation. The drug dispensing personnel will offer the corresponding drug, however with a random drug number. Serial Serum 25- hydroxy-Vitamin D levels, obtained every three months, will be declassified at the end of the study (24 months after enrollment), or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

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

Control group

Patients will receive placebo, 2 capsules per day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cholecalciferol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Natural Vitamin D3

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No