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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Sir Charles Gairdner Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier:
NCT00798993
First received: November 26, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (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

  Eligibility

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

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

Locations
Australia, Western Australia
Sir Charles Gairdner Hospital Not yet recruiting
Perth, Western Australia, Australia, 6009
Contact: Neil C Boudville, MBBS     61-8-9346-2799     neil.boudville@uwa.edu.au    
Sub-Investigator: Neil C Boudville, MBBS            
Sponsors and Collaborators
Sir Charles Gairdner Hospital
Investigators
Principal Investigator: Ben Bull Sir Charles Gairdner Hospital
Study Director: Neil Boudville Sir Charles Gairdner Hospital
  More Information

No publications provided

Responsible Party: Ben Bull, Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier: NCT00798993     History of Changes
Other Study ID Numbers: SCGH25OHD2008
Study First Received: November 26, 2008
Last Updated: November 26, 2008
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Cholecalciferol
Hydroxycholecalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 23, 2013