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:

MedlinePlus related topics: Chronic Kidney Disease Kidney Diseases Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

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
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

No publications provided by Creighton University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Armas LA, Andukuri R, Barger-Lux J, Heaney RP, Lund R. 25-Hydroxyvitamin D response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2012 Sep;7(9):1428-34. doi: 10.2215/CJN.12761211. Epub 2012 Jul 12.


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

ClinicalTrials.gov processed this record on March 03, 2015

To Top