Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

NCT05860270 | Recruiting Phase 4 DMC

• 1 other identifier: Vitamin D and Peritonitis
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Dialysis-associated Peritonitis; Vitamin D Deficiency

Keywords

Peritoneal dialysis; Peritonitis; Cholecalciferol

Outcome Measures

Primary Outcomes (1)

• Hazard Ratio of Subsequent peritonitis

  Risk of a subsequent episode of peritoneal dialysis related peritonitis in the interventional group compared with the control group measured by Hazard Ratio.

  24 months

Secondary Outcomes (3)

• rate of Systemic infection

  24 months

• rate of Technique failure due to peritonitis

  24 months

• rate of Death or transfer to hemodialysis with reasons other than peritonitis

  24 months

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Control group

PLACEBO COMPARATOR

Patients will receive placebo, 2 capsules per day.

Drug: Placebo

Interventions

Cholecalciferol DRUG

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

Also known as: Natural Vitamin D3

Treatment group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Third Hospital: collaborator
• Peking University People's Hospital: collaborator
• Beijing Haidian Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator
• Miyun District of Peking University First Hospital: collaborator
• Beijing Fangshan District Hospital of Traditional Chinese Medicine: collaborator
• Peking University International Hospital: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• Capital Medical University: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Peritonitis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jie Dong

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Dong, Professor

CONTACT

13911841538; jie.dong@bjmu.edu.cn

Zhikai Yang

CONTACT

13671248465; seapollar@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of PD center

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 16, 2023
• Study Start: June 15, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)