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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peritoneal Dialysis-associated Peritonitis, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol (2000iu qd)
* Other: Routine therapy for PD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD | Drug: Cholecalciferol (2000iu qd)<br>* Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD<br>* Other names: Natural Vitamin D3;Other: Routine therapy for PD<br>* Patients randomized to the placebo group will receive routine therapy for PD.<br>|
| Placebo Comparator: Control group<br>Patients randomized to the placebo group will receive routine therapy for PD. | Other: Routine therapy for PD<br>* Patients randomized to the placebo group will receive routine therapy for PD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholecalciferol, Peritoneal dialysis, Peritonitis