Status:
COMPLETED
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
Lead Sponsor:
Peking University First Hospital
Conditions:
Peritoneal Dialysis-associated Peritonitis
Vitamin D Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03264625
Start Date
September 30 2017
End Date
July 30 2021
Last Update
August 18 2021
Active Locations (1)
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1
Peking University First Hospital
Beijing, China