The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis

August 12, 2021 updated by: Dong Jie, Peking University First Hospital

This is a pilot randomized, controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine the feasibility of a future full-scale RCT exploring if oral administration of vitamin D3 could reduce the risk of subsequent Peritoneal dialysis-related (PD-related) peritonitis.

Aims of the study:

Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who have recovered from a recent episode of peritonitis.

Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among patients on peritoneal dialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be screened for eligibility one month after the onset of PD-related peritonitis, those who meet the inclusion criteria will be enrolled in this study.

All consenting participants will be randomized into the vitamin D treatment group or the control group, general information and baseline biochemistry data would be collected. Patients in the treatment group will be treated with oral Cholecalciferol (2000IU/day) apart from routine treatment for PD. Those in the control group will receive routine treatment for PD. Both groups will be followed for 12 months. During the observational period, any onset of subsequent peritonitis will be recorded, serum 25(OH)D, biochemical indices will be measured every 3 months. Follow up would take place frequently, any outcome events would be recorded.

Aims and hypotheses:

Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who have recovered from a recent episode of peritonitis.

Hypothesis1: A large、full-scale randomized controlled trail on the effects of oral vitamin D on the risk for peritonitis among PD patients is feasible.

Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among patients on peritoneal dialysis.

Hypothesis 2: Oral supplementation of vitamin D will reduce the risk of subsequent peritoneal dialysis.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Medically stable and receiving peritoneal dialysis (PD) for>1 months
  2. Age at least 18 years.
  3. Serum 25(OH)D<75nmol/l (30ng/ml)
  4. Adequate dialysis on evaluation, weekly Kt/V ≥ 1.5 and no clinical uremic symptoms

Exclusion Criteria:

  1. Receive Vitamin D2/D3 or drugs known to alter serum 25-hydroxyvitamin D (25(OH)D) levels during the previous 12 months;
  2. History of allergic reaction to Cholecalciferol;
  3. Current or past malignant disease, active hepatitis or hepatic failure, acute systemic infection, active autoimmune diseases, severe digestive malabsorption or eating disorder, HIV/AIDS;
  4. A high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to hemodialysis (HD) or drop-out due to socioeconomic causes within 6 months;
  5. Pregnant or breastfeeding;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group
Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
Drug: Cholecalciferol (2000iu qd)
Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
Other Names:
  • Natural Vitamin D3
Other: Routine therapy for PD
Patients randomized to the placebo group will receive routine therapy for PD.
PLACEBO_COMPARATOR: Control group
Patients randomized to the placebo group will receive routine therapy for PD.
Other: Routine therapy for PD
Patients randomized to the placebo group will receive routine therapy for PD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate of the trial
Time Frame: From date of randomization until 1 year after the randomization of last participant.
Recruitment rate of patients screened for the trial measured by percentage.
From date of randomization until 1 year after the randomization of last participant.
Retention rate of the trial
Time Frame: From date of randomization until 1 year after the randomization of last participant
Retention rate of included patients in the trial measured by percentage.
From date of randomization until 1 year after the randomization of last participant
Adherence rate of the trial
Time Frame: From date of randomization until 1 year after the randomization of last participant.
Percentage of participants adherent to the dosing regimen of vitamin D in the trial.
From date of randomization until 1 year after the randomization of last participant.
Incidence of adverse events
Time Frame: From date of randomization until 1 year after the randomization of last participant.
Incidence of adverse events measured by number of events per patient-month
From date of randomization until 1 year after the randomization of last participant.
Change in serum 25(OH)D level
Time Frame: From date of randomization until 1 year after the randomization of last participant
Change in serum 25(OH)D level between baseline and 12 months measured by ng/ml.
From date of randomization until 1 year after the randomization of last participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in risk of a subsequent peritonitis measured by Hazard Ratio.
Time Frame: From date of randomization until the date of subsequent peritonitis, assessed up to 1 year.
Risk of a subsequent peritoneal dialysis related peritonitis in the interventional group compared with the control group measured by Hazard Ratio.
From date of randomization until the date of subsequent peritonitis, assessed up to 1 year.
Probability of participants who recovered after subsequent peritoneal dialysis related peritonitis.
Time Frame: From date of randomization until the date of documented death, assessed up to 1 year.
Probability of participants who recovered after peritoneal dialysis-related peritonitis measured by percentage.
From date of randomization until the date of documented death, assessed up to 1 year.
Risk of participants who died because of subsequent peritoneal dialysis related peritonitis.
Time Frame: From date of randomization until the date of documented death, assessed up to 1 year.
Risk of participants who died because of peritoneal dialysis-related peritonitis measured by percentage.
From date of randomization until the date of documented death, assessed up to 1 year.
Risk of participants who are transitioned to hemodialysis because of subsequent peritoneal dialysis related peritonitis.
Time Frame: From date of randomization until the date of documented transition to hemodialysis because of peritoneal dialysis related peritonitis, assessed up to 1 year.
Risk of patients who are transferred to hemodialysis because of peritoneal dialysis related peritonitis measured by percentage.
From date of randomization until the date of documented transition to hemodialysis because of peritoneal dialysis related peritonitis, assessed up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2017

Primary Completion (ACTUAL)

May 28, 2021

Study Completion (ACTUAL)

July 30, 2021

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

August 28, 2017

First Posted (ACTUAL)

August 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D, RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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