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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Dietary Supplement: cholecalciferol Dietary Supplement: placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : September 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
Sponsors and Collaborators
Creighton University
Dialysis Clinic, Inc.
Investigators
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Principal Investigator: Richard Lund, MD Creighton University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laura Armas, Assistant Professor, Creighton University
ClinicalTrials.gov Identifier: NCT00511225    
Other Study ID Numbers: 07-14571
First Posted: August 3, 2007    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012
Keywords provided by Laura Armas, Creighton University:
dialysis
Vitamin D
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Cholecalciferol
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents