End Stage Renal Disease
Conditions
Keywords
dialysis, Vitamin D
Brief summary
Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.
Detailed description
The proposed study is be a randomized, double-blind, placebo-controlled trial of supplementation with oral vitamin D3. Each subject will take a once-weekly capsule containing vitamin D3 or a an identical-appearing placebo for a treatment period of 15 weeks. Subjects will be assessed for Bone pain and tenderness, Neuromuscular function, physical performance score, and Quality of life assessment. A subset of subjects will have bone biopsies performed before and after intervention.
Interventions
DIETARY_SUPPLEMENTcholecalciferol
10,000 IU weekly
DIETARY_SUPPLEMENTplacebo
placebo capsule
Sponsors
Dialysis Clinic, Inc.
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* On dialysis * Likely to be able to complete the study * At least minimally ambulatory, with or without a walking aid (i.e., cane or walker) * Able to complete the various questionnaires interactively with the research nurse * Venous access that can be accomplished without unusual difficulty.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in physical performance score | 15 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Bone pain and tenderness | 15 weeks |
| Neuromuscular function tests | 15 weeks |
| Quality of life assessment | 15 weeks |
Countries
United States
Outcome results
None listed