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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:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • change in physical performance score [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone pain and tenderness [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Neuromuscular function tests [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Quality of life assessment [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: United States: Institutional Review Board

Keywords provided by 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 September 30, 2016