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

NCT03264625 | Completed Phase 2 DMC

• 1 other identifier: Vitamin D, RCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis-associated Peritonitis; Vitamin D Deficiency

Keywords

Cholecalciferol; Peritoneal dialysis; Peritonitis

Outcome Measures

Primary Outcomes (5)

• Recruitment rate of the trial

  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

  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

  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

  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

  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 Outcomes (4)

• Difference in risk of a subsequent peritonitis 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.

  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.

  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.

  From date of randomization until the date of documented transition to hemodialysis because of peritoneal dialysis related peritonitis, assessed up to 1 year.

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD

Drug: Cholecalciferol (2000iu qd); Other: Routine therapy for PD

Control group

PLACEBO COMPARATOR

Patients randomized to the placebo group will receive routine therapy for PD.

Other: Routine therapy for PD

Interventions

Cholecalciferol (2000iu qd) DRUG

Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD

Also known as: Natural Vitamin D3

Treatment group

Routine therapy for PD OTHER

Patients randomized to the placebo group will receive routine therapy for PD.

Control group; Treatment group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Receive Vitamin D2/D3 or drugs known to alter serum 25-hydroxyvitamin D (25(OH)D) levels during the previous 12 months;
• History of allergic reaction to Cholecalciferol;
• Current or past malignant disease, active hepatitis or hepatic failure, acute systemic infection, active autoimmune diseases, severe digestive malabsorption or eating disorder, HIV/AIDS;
• 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;
• Pregnant or breastfeeding;

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

Related Publications (3)

• Pi HC, Ren YP, Wang Q, Xu R, Dong J. Serum 25-Hydroxyvitamin D Level Could Predict the Risk for Peritoneal Dialysis-Associated Peritonitis. Perit Dial Int. 2015 Dec;35(7):729-35. doi: 10.3747/pdi.2014.00177. Epub 2015 Jul 29.

  PMID: 26224791 BACKGROUND

• Armas LA, Andukuri R, Barger-Lux J, Heaney RP, Lund R. 25-Hydroxyvitamin D response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2012 Sep;7(9):1428-34. doi: 10.2215/CJN.12761211. Epub 2012 Jul 12.

  PMID: 22798536 BACKGROUND

• Zhang YH, Xu X, Pi HC, Yang ZK, Johnson DW, Dong J. The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial. Trials. 2019 Nov 28;20(1):657. doi: 10.1186/s13063-019-3784-7.

  PMID: 31779675 DERIVED

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 Universiy First Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of PD center

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: August 29, 2017
• Study Start: September 30, 2017
• Primary Completion: May 28, 2021
• Study Completion: July 30, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)