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
  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:


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
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
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

No publications provided by Creighton University

Additional 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
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014