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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00511225
Recruitment Status : Completed
First Posted : August 3, 2007
Last Update Posted : July 3, 2012
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Laura Armas, Creighton University

Tracking Information
First Submitted Date  ICMJE August 1, 2007
First Posted Date  ICMJE August 3, 2007
Last Update Posted Date July 3, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
change in physical performance score [ Time Frame: 15 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
  • Bone pain and tenderness [ Time Frame: 15 weeks ]
  • Neuromuscular function tests [ Time Frame: 15 weeks ]
  • Quality of life assessment [ Time Frame: 15 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease
Official Title  ICMJE Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE
  • Dietary Supplement: cholecalciferol
    10,000 IU weekly
    Other Name: Maximum D3®,Pro-Pharma LLA, Kirksville, MO
  • Dietary Supplement: placebo
    placebo capsule
Study Arms  ICMJE
  • Active Comparator: 1
    Will receive 10,000 IU of cholecalciferol weekly
    Intervention: Dietary Supplement: cholecalciferol
  • Placebo Comparator: 2
    Will receive a identical appearing placebo weekly
    Intervention: Dietary Supplement: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2007)
60
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00511225
Other Study ID Numbers  ICMJE 07-14571
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Laura Armas, Creighton University
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Creighton University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Dialysis Clinic, Inc.
Investigators  ICMJE
Principal Investigator: Richard Lund, MD Creighton University
PRS Account Creighton University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP