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History of Changes for Study: NCT00511225
Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease (Neph)
Latest version (submitted June 29, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 2, 2007 None (earliest Version on record)
2 April 8, 2008 Recruitment Status, Study Status, Study Design, Contacts/Locations and Sponsor/Collaborators
3 January 6, 2009 Study Status
4 July 28, 2009 Study Status
5 January 27, 2010 Study Status
6 August 30, 2010 Recruitment Status, Study Status and Contacts/Locations
7 September 1, 2011 Sponsor/Collaborators and Study Status
8 June 29, 2012 Recruitment Status, Study Status and Study Design
Comparison Format:

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Study NCT00511225
Submitted Date:  August 2, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: 07-14571
Brief Title: Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease (Neph)
Official Title: Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2007
Overall Status: Not yet recruiting
Study Start: September 2007
Primary Completion:
Study Completion: January 2009 [Anticipated]
First Submitted: August 1, 2007
First Submitted that
Met QC Criteria:
August 2, 2007
First Posted: August 3, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 2, 2007
Last Update Posted: August 3, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Creighton University
Responsible Party:
Collaborators: Dialysis Clinic, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: End Stage Renal Disease
Keywords: dialysis
Vitamin D
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: 1
Will receive 10,000 IU of cholecalciferol weekly
Dietary Supplement: cholecalciferol
10,000 IU weekly
Other Names:
  • Maximum D3®,Pro-Pharma LLA, Kirksville, MO
Placebo Comparator: 2
Will receive a identical appearing placebo weekly
Dietary Supplement: placebo
placebo capsule
Open or close this module Outcome Measures
Primary Outcome Measures:
1. change in physical performance score
[ Time Frame: 15 weeks ]

Secondary Outcome Measures:
1. Bone pain and tenderness
[ Time Frame: 15 weeks ]

2. Neuromuscular function tests
[ Time Frame: 15 weeks ]

3. Quality of life assessment
[ Time Frame: 15 weeks ]

Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Susan Dowell, RN, PhD
Telephone: 402-280-4676
Email: sdowell@creighton.edu
Central Contact Backup: Radha Andukuri, MDDS
Telephone: 402-280-4241
Email: RadhaAndukuri@creighton.edu
Study Officials: Richard Lund, MD
Principal Investigator
Creighton University
Locations: United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
Contact:Sub-Investigator: Radha Andukuri, MDDS
Contact:Sub-Investigator: Laura Armas, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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