Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients
NCT ID: NCT00798993
Last Updated: 2013-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
19 participants
INTERVENTIONAL
2009-01-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Structured exercise program
Participants will be randomised at 3 months into either this group or the comparator of usual exercise.
Structured Exercise program
30 minutes on an exercise bicycle during every dialysis
Vitamin D
Cholecalciferol 2000U per day will be given to all participants for the duration of the study
Cholecalciferol (25-Hydroxyvitamin D)
Cholecalciferol 2000U per day will be given for duration of study to all participants
Usual exercise
Participants randomised to this arm, at 3 months, will continue on their usual exercise routine
Usual exercise
Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months
Interventions
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Structured Exercise program
30 minutes on an exercise bicycle during every dialysis
Cholecalciferol (25-Hydroxyvitamin D)
Cholecalciferol 2000U per day will be given for duration of study to all participants
Usual exercise
Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Sir Charles Gairdner Hospital
OTHER
Responsible Party
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Neil Boudville
Associate Professor
Principal Investigators
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Ben Bull
Role: PRINCIPAL_INVESTIGATOR
Sir Charles Gairdner Hospital
Neil Boudville
Role: STUDY_DIRECTOR
Sir Charles Gairdner Hospital
Locations
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Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Countries
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Other Identifiers
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SCGH25OHD2008
Identifier Type: -
Identifier Source: org_study_id
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