Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease (Neph)
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|ClinicalTrials.gov Identifier: NCT00511225|
Recruitment Status : Completed
First Posted : August 3, 2007
Last Update Posted : July 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Dietary Supplement: cholecalciferol Dietary Supplement: placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||September 2011|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511225
|United States, Nebraska|
|Omaha, Nebraska, United States, 68178|
|Principal Investigator:||Richard Lund, MD||Creighton University|