Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease
Not Applicable
Withdrawn
- Conditions
- Chronic Kidney Diseases
- Interventions
- Dietary Supplement: Cholecalciferol
- Registration Number
- NCT04167111
- Lead Sponsor
- University of Nebraska
- Brief Summary
Feasibility of dose adjustment to reach a 6 month 25-hydroxy vitamin D level of 35-50 ng/ml in end stage renal disease patients
- Detailed Description
Pilot study to test the feasibility of adjusting doses based on a prespecified algorithm to reach a 6 month 25(OH)D level of 35-50 ng/ml in end stage renal disease patients.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- likely be able to complete the study, >3 months on hemodialysis, receiving standard of care through their nephrologist.
Exclusion Criteria
- on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that interfere with vitamin D absorption, taking vitamin D >800 IU per day, 25(OH)D level >30 ng/ml, glucocorticoids, anticonvulsants or drug therapies for osteoporosis, pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Vitamin D 4000 Cholecalciferol At baseline, if subjects 25(OH)D levels are 12-19.9, they will be started on 4000 IU per day. Vitamin D 2400 Cholecalciferol At baseline, if subjects 25(OH)D levels are 20-30, they will be started on 2400 IU per day.
- Primary Outcome Measures
Name Time Method 25(OH)D level 6 months 25(OH)D level
- Secondary Outcome Measures
Name Time Method