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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients

Conditions
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End Stage Kidney Disease

Intervention / Treatment
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* Other: Structured Exercise program
* Drug: Cholecalciferol (25-Hydroxyvitamin D)
* Other: Usual exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Structured exercise program<br>Participants will be randomised at 3 months into either this group or the comparator of usual exercise. | Other: Structured Exercise program<br>* 30 minutes on an exercise bicycle during every dialysis<br>|
| Experimental: Vitamin D<br>Cholecalciferol 2000U per day will be given to all participants for the duration of the study | Drug: Cholecalciferol (25-Hydroxyvitamin D)<br>* Cholecalciferol 2000U per day will be given for duration of study to all participants<br>|
| Placebo Comparator: Usual exercise<br>Participants randomised to this arm, at 3 months, will continue on their usual exercise routine | Other: Usual exercise<br>* Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity - modified shuttle walk test |  | Basesline, 3 & 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Falls |  | continuous | 
| Pulse wave velocity |  | baseline, 3 & 6 months | 
| Bioimpedance |  | Baseline, 3 & 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney failure, 25 hydroxyvitamin D, falls, exercise, quadriceps strength