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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264625
• Other study ID #: Vitamin D, RCT
• Status: Completed
• Phase: Phase 2
• Start date: September 30, 2017
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Peritoneal Dialysis-associated Peritonitis
• Peritonitis
• Vitamin D Deficiency

Intervention

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

Other:
• Routine therapy for PD
Patients randomized to the placebo group will receive routine therapy for PD.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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.
Primary	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.
Primary	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	Difference in risk of a subsequent peritonitis measured by Hazard Ratio.	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.
Secondary	Probability of participants who recovered after subsequent peritoneal dialysis related peritonitis.	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.
Secondary	Risk of participants who died because of subsequent peritoneal dialysis related peritonitis.	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.
Secondary	Risk of participants who are transitioned to hemodialysis because of subsequent peritoneal dialysis related peritonitis.	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.