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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00798993




Registration number
NCT00798993
Ethics application status
Date submitted
26/11/2008
Date registered
27/11/2008
Date last updated
10/06/2013

Titles & IDs
Public title
Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients
Scientific title
The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients
Secondary ID [1] 0 0
SCGH25OHD2008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Structured Exercise program
Treatment: Drugs - Cholecalciferol (25-Hydroxyvitamin D)
Other interventions - Usual exercise

Active Comparator: Structured exercise program - Participants will be randomised at 3 months into either this group or the comparator of usual exercise.

Experimental: Vitamin D - Cholecalciferol 2000U per day will be given to all participants for the duration of the study

Placebo Comparator: Usual exercise - Participants randomised to this arm, at 3 months, will continue on their usual exercise routine


Other interventions: Structured Exercise program
30 minutes on an exercise bicycle during every dialysis

Treatment: Drugs: Cholecalciferol (25-Hydroxyvitamin D)
Cholecalciferol 2000U per day will be given for duration of study to all participants

Other interventions: Usual exercise
Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Exercise capacity - modified shuttle walk test
Timepoint [1] 0 0
Basesline, 3 & 6 months
Secondary outcome [1] 0 0
Quality of life with KDQOL
Timepoint [1] 0 0
Baseline, 3 & 6 months
Secondary outcome [2] 0 0
Quadriceps Strength
Timepoint [2] 0 0
Baseline, 3 & 6 months
Secondary outcome [3] 0 0
Serum phosphate
Timepoint [3] 0 0
baselibe, 3 & 6 months
Secondary outcome [4] 0 0
Feeling thermometer
Timepoint [4] 0 0
Baseline, 3 & 6 months
Secondary outcome [5] 0 0
Timed up and go
Timepoint [5] 0 0
baseline, 3 & 6 months
Secondary outcome [6] 0 0
Falls
Timepoint [6] 0 0
continuous
Secondary outcome [7] 0 0
Pulse wave velocity
Timepoint [7] 0 0
baseline, 3 & 6 months
Secondary outcome [8] 0 0
Bioimpedance
Timepoint [8] 0 0
Baseline, 3 & 6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Sir Charles Gairdner Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00798993
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Bull
Address 0 0
Sir Charles Gairdner Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00798993