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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)

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cholecalciferol

placebo

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring dialysis, Vitamin D

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Creighton University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Will receive 10,000 IU of cholecalciferol weekly

Will receive a identical appearing placebo weekly

Outcomes

Primary Outcome Measures

change in physical performance score

Secondary Outcome Measures

Bone pain and tenderness

Neuromuscular function tests

Quality of life assessment

Full Information

NCT ID

NCT00511225

First Posted

August 1, 2007

Last Updated

June 29, 2012

Sponsor

Creighton University

Collaborators

Dialysis Clinic, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00511225

Brief Title

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

Acronym

Neph

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Creighton University

Collaborators

Dialysis Clinic, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

dialysis, Vitamin D

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Will receive 10,000 IU of cholecalciferol weekly

Arm Title

Arm Type

Placebo Comparator

Arm Description

Will receive a identical appearing placebo weekly

Intervention Type

Dietary Supplement

Intervention Name(s)

cholecalciferol

Other Intervention Name(s)

Maximum D3®,Pro-Pharma LLA, Kirksville, MO

Intervention Description

10,000 IU weekly

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

placebo capsule

Primary Outcome Measure Information:

Title

change in physical performance score

Time Frame

15 weeks

Secondary Outcome Measure Information:

Title

Bone pain and tenderness

Time Frame

15 weeks

Title

Neuromuscular function tests

Time Frame

15 weeks

Title

Quality of life assessment

Time Frame

15 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Lund, MD

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68178

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28506446

Citation

Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D3 response to native vitamin D2 and D3 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.

Results Reference

derived

PubMed Identifier

22798536

Citation

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.

Results Reference

derived

Learn more about this trial

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

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