Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease (Neph)

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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

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

MedlinePlus related topics: Kidney Diseases Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

change in physical performance score [ Time Frame: 15 weeks ]

Secondary Outcome Measures :

Bone pain and tenderness [ Time Frame: 15 weeks ]
Neuromuscular function tests [ Time Frame: 15 weeks ]
Quality of life assessment [ Time Frame: 15 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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

Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D(3) response to native vitamin D(2) and D(3) Supplementation in patients with chronic kidney disease on hemodialysis. Clin Nutr. 2018 Jun;37(3):1041-1045. doi: 10.1016/j.clnu.2017.04.020. Epub 2017 Apr 30.

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.

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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 Nutrients Growth Substances Bone Density Conservation Agents

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