Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease (Neph)
|End Stage Renal Disease||Dietary Supplement: cholecalciferol Dietary Supplement: placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease|
- change in physical performance score [ Time Frame: 15 weeks ]
- Bone pain and tenderness [ Time Frame: 15 weeks ]
- Neuromuscular function tests [ Time Frame: 15 weeks ]
- Quality of life assessment [ Time Frame: 15 weeks ]
|Study Start Date:||September 2007|
|Study Completion Date:||September 2011|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Will receive 10,000 IU of cholecalciferol weekly
Dietary Supplement: cholecalciferol
10,000 IU weekly
Other Name: Maximum D3®,Pro-Pharma LLA, Kirksville, MO
Placebo Comparator: 2
Will receive a identical appearing placebo weekly
Dietary Supplement: placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511225
|United States, Nebraska|
|Omaha, Nebraska, United States, 68178|
|Principal Investigator:||Richard Lund, MD||Creighton University|