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Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease (Neph)
This study has been completed.
Sponsor:
Creighton University
Collaborator:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Laura Armas, Creighton University
ClinicalTrials.gov Identifier:
NCT00511225
First received: August 1, 2007
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
| End Stage Renal Disease | Dietary Supplement: cholecalciferol Dietary Supplement: placebo |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Laura Armas, Creighton University:
Primary Outcome Measures:
- change in physical performance score [ Time Frame: 15 weeks ]
Secondary Outcome Measures:
- Bone pain and tenderness [ Time Frame: 15 weeks ]
- Neuromuscular function tests [ Time Frame: 15 weeks ]
- Quality of life assessment [ Time Frame: 15 weeks ]
| Enrollment: | 47 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
placebo capsule
|
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.
Eligibility| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00511225
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511225
Locations
| United States, Nebraska | |
| Creighton University | |
| Omaha, Nebraska, United States, 68178 | |
Sponsors and Collaborators
Creighton University
Dialysis Clinic, Inc.
Investigators
| Principal Investigator: | Richard Lund, MD | Creighton University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Laura Armas, Assistant Professor, Creighton University |
| ClinicalTrials.gov Identifier: | NCT00511225 History of Changes |
| Other Study ID Numbers: |
07-14571 |
| Study First Received: | August 1, 2007 |
| Last Updated: | June 29, 2012 |
Keywords provided by Laura Armas, Creighton University:
|
dialysis Vitamin D |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency Vitamins Vitamin D |
Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 23, 2017