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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
Patients randomized to the placebo group will receive routine therapy for PD.
Peking University First Hospital
Beijing, China
Recruitment rate of the trial
Recruitment rate of patients screened for the trial measured by percentage.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From date of randomization until 1 year after the randomization of last participant
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.
Time frame: 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.
Probability of participants who recovered after peritoneal dialysis-related peritonitis measured by percentage.
Time frame: 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.
Risk of participants who died because of peritoneal dialysis-related peritonitis measured by percentage.
Time frame: 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.
Risk of patients who are transferred to hemodialysis because of peritoneal dialysis related peritonitis measured by percentage.
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.
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