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

This study has been completed.
Information provided by (Responsible Party):
Neil Boudville, Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier:
First received: November 26, 2008
Last updated: June 6, 2013
Last verified: June 2013
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.

Condition Intervention Phase
End Stage Kidney Disease
Other: Structured Exercise program
Drug: Cholecalciferol (25-Hydroxyvitamin D)
Other: Usual exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients

Resource links provided by NLM:

Further study details as provided by Sir Charles Gairdner Hospital:

Primary Outcome Measures:
  • Exercise capacity - modified shuttle walk test [ Time Frame: Basesline, 3 & 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life with KDQOL [ Time Frame: Baseline, 3 & 6 months ] [ Designated as safety issue: No ]
  • Quadriceps Strength [ Time Frame: Baseline, 3 & 6 months ] [ Designated as safety issue: No ]
  • Serum phosphate [ Time Frame: baselibe, 3 & 6 months ] [ Designated as safety issue: No ]
  • Feeling thermometer [ Time Frame: Baseline, 3 & 6 months ] [ Designated as safety issue: No ]
  • Timed up and go [ Time Frame: baseline, 3 & 6 months ] [ Designated as safety issue: No ]
  • Falls [ Time Frame: continuous ] [ Designated as safety issue: No ]
  • Pulse wave velocity [ Time Frame: baseline, 3 & 6 months ] [ Designated as safety issue: No ]
  • Bioimpedance [ Time Frame: Baseline, 3 & 6 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Structured exercise program
Participants will be randomised at 3 months into either this group or the comparator of usual exercise.
Other: Structured Exercise program
30 minutes on an exercise bicycle during every dialysis
Experimental: Vitamin D
Cholecalciferol 2000U per day will be given to all participants for the duration of the study
Drug: Cholecalciferol (25-Hydroxyvitamin D)
Cholecalciferol 2000U per day will be given for duration of study to all participants
Placebo Comparator: Usual exercise
Participants randomised to this arm, at 3 months, will continue on their usual exercise routine
Other: Usual exercise
Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00798993

Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Sir Charles Gairdner Hospital
Principal Investigator: Ben Bull Sir Charles Gairdner Hospital
Study Director: Neil Boudville Sir Charles Gairdner Hospital
  More Information

Responsible Party: Neil Boudville, Associate Professor, Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier: NCT00798993     History of Changes
Other Study ID Numbers: SCGH25OHD2008 
Study First Received: November 26, 2008
Last Updated: June 6, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Sir Charles Gairdner Hospital:
Chronic kidney failure
25 hydroxyvitamin D
quadriceps strength

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016