Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease
Not Applicable
Completed
- Conditions
- End Stage Renal Disease
- Registration Number
- NCT00511225
- Lead Sponsor
- Creighton University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change in physical performance score 15 weeks
- Secondary Outcome Measures
Name Time Method Bone pain and tenderness 15 weeks Neuromuscular function tests 15 weeks Quality of life assessment 15 weeks
Trial Locations
- Locations (1)
Creighton University
🇺🇸Omaha, Nebraska, United States
Creighton University🇺🇸Omaha, Nebraska, United States