Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03264625
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Dong Jie, Peking University First Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Peritoneal Dialysis-associated Peritonitis Vitamin D Deficiency Drug: Cholecalciferol (2000iu qd) Other: Routine therapy for PD Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
Actual Study Start Date : September 30, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin D

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 Name: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264625


Contacts
Layout table for location contacts
Contact: Jie Dong 13911841538 jie.dong@bjmu.edu.cn

Locations
Layout table for location information
China
Peking University First Hospital Recruiting
Beijing, China
Contact: Jie Dong    13911841538      
Sponsors and Collaborators
Peking University First Hospital
Investigators
Layout table for investigator information
Study Director: Jie Dong Peking Universiy First Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dong Jie, Director of PD center, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03264625    
Other Study ID Numbers: Vitamin D, RCT
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong Jie, Peking University First Hospital:
Cholecalciferol
Peritoneal dialysis
Peritonitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Peritonitis
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents