Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients
The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2008
CompletedFirst Posted
Study publicly available on registry
November 27, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJune 10, 2013
June 1, 2013
2.7 years
November 26, 2008
June 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise capacity - modified shuttle walk test
Basesline, 3 & 6 months
Secondary Outcomes (8)
Quality of life with KDQOL
Baseline, 3 & 6 months
Quadriceps Strength
Baseline, 3 & 6 months
Serum phosphate
baselibe, 3 & 6 months
Feeling thermometer
Baseline, 3 & 6 months
Timed up and go
baseline, 3 & 6 months
- +3 more secondary outcomes
Study Arms (3)
Structured exercise program
ACTIVE COMPARATORParticipants will be randomised at 3 months into either this group or the comparator of usual exercise.
Vitamin D
EXPERIMENTALCholecalciferol 2000U per day will be given to all participants for the duration of the study
Usual exercise
PLACEBO COMPARATORParticipants randomised to this arm, at 3 months, will continue on their usual exercise routine
Interventions
30 minutes on an exercise bicycle during every dialysis
Cholecalciferol 2000U per day will be given for duration of study to all participants
Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ben Bull
Sir Charles Gairdner Hospital
- STUDY DIRECTOR
Neil Boudville
Sir Charles Gairdner Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 26, 2008
First Posted
November 27, 2008
Study Start
January 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
June 10, 2013
Record last verified: 2013-06