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Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients

Primary Purpose

End Stage Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Structured Exercise program
Cholecalciferol (25-Hydroxyvitamin D)
Usual exercise
Sponsored by
Sir Charles Gairdner Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Kidney Disease focused on measuring Chronic kidney failure, 25 hydroxyvitamin D, falls, exercise, quadriceps strength

Eligibility Criteria

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

Inclusion Criteria:

  1. Stable on dialysis for at least 3 months
  2. Able to obtain informed consent
  3. Medically stable
  4. Dialysis adequacy at target for small solute clearance (ie Kt/V>1.2 or Urea reduction ratio>65%)
  5. Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline

Exclusion Criteria:

  1. Limb Amputation
  2. Impaired cognition
  3. Impaired vision
  4. Haemoglobin concentration < 110g/L
  5. Change in Erythropoiesis stimulating agent dose over the last 2 months
  6. Unable or unwilling to comply with exercise program

Sites / Locations

  • Sir Charles Gairdner Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Structured exercise program

Vitamin D

Usual exercise

Arm Description

Participants will be randomised at 3 months into either this group or the comparator of usual exercise.

Cholecalciferol 2000U per day will be given to all participants for the duration of the study

Participants randomised to this arm, at 3 months, will continue on their usual exercise routine

Outcomes

Primary Outcome Measures

Exercise capacity - modified shuttle walk test

Secondary Outcome Measures

Quality of life with KDQOL
Quadriceps Strength
Serum phosphate
Feeling thermometer
Timed up and go
Falls
Pulse wave velocity
Bioimpedance

Full Information

First Posted
November 26, 2008
Last Updated
June 6, 2013
Sponsor
Sir Charles Gairdner Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00798993
Brief Title
Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients
Official Title
The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Charles Gairdner Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin D insufficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease
Keywords
Chronic kidney failure, 25 hydroxyvitamin D, falls, exercise, quadriceps strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured exercise program
Arm Type
Active Comparator
Arm Description
Participants will be randomised at 3 months into either this group or the comparator of usual exercise.
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Cholecalciferol 2000U per day will be given to all participants for the duration of the study
Arm Title
Usual exercise
Arm Type
Placebo Comparator
Arm Description
Participants randomised to this arm, at 3 months, will continue on their usual exercise routine
Intervention Type
Other
Intervention Name(s)
Structured Exercise program
Intervention Description
30 minutes on an exercise bicycle during every dialysis
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol (25-Hydroxyvitamin D)
Intervention Description
Cholecalciferol 2000U per day will be given for duration of study to all participants
Intervention Type
Other
Intervention Name(s)
Usual exercise
Intervention Description
Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months
Primary Outcome Measure Information:
Title
Exercise capacity - modified shuttle walk test
Time Frame
Basesline, 3 & 6 months
Secondary Outcome Measure Information:
Title
Quality of life with KDQOL
Time Frame
Baseline, 3 & 6 months
Title
Quadriceps Strength
Time Frame
Baseline, 3 & 6 months
Title
Serum phosphate
Time Frame
baselibe, 3 & 6 months
Title
Feeling thermometer
Time Frame
Baseline, 3 & 6 months
Title
Timed up and go
Time Frame
baseline, 3 & 6 months
Title
Falls
Time Frame
continuous
Title
Pulse wave velocity
Time Frame
baseline, 3 & 6 months
Title
Bioimpedance
Time Frame
Baseline, 3 & 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable on dialysis for at least 3 months Able to obtain informed consent Medically stable Dialysis adequacy at target for small solute clearance (ie Kt/V>1.2 or Urea reduction ratio>65%) Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline Exclusion Criteria: Limb Amputation Impaired cognition Impaired vision Haemoglobin concentration < 110g/L Change in Erythropoiesis stimulating agent dose over the last 2 months Unable or unwilling to comply with exercise program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Bull
Organizational Affiliation
Sir Charles Gairdner Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil Boudville
Organizational Affiliation
Sir Charles Gairdner Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

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Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients

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