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

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ClinicalTrials.gov Identifier: NCT00798993
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : June 10, 2013
Sponsor:
Information provided by (Responsible Party):
Neil Boudville, Sir Charles Gairdner Hospital

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2009
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Calcifediol
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Exercise capacity - modified shuttle walk test [ Time Frame: Basesline, 3 & 6 months ]

Secondary Outcome Measures :
  1. Quality of life with KDQOL [ Time Frame: Baseline, 3 & 6 months ]
  2. Quadriceps Strength [ Time Frame: Baseline, 3 & 6 months ]
  3. Serum phosphate [ Time Frame: baselibe, 3 & 6 months ]
  4. Feeling thermometer [ Time Frame: Baseline, 3 & 6 months ]
  5. Timed up and go [ Time Frame: baseline, 3 & 6 months ]
  6. Falls [ Time Frame: continuous ]
  7. Pulse wave velocity [ Time Frame: baseline, 3 & 6 months ]
  8. Bioimpedance [ Time Frame: Baseline, 3 & 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798993


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

Responsible Party: Neil Boudville, Associate Professor, Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier: NCT00798993     History of Changes
Other Study ID Numbers: SCGH25OHD2008
First Posted: November 27, 2008    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: June 2013

Keywords provided by Neil Boudville, 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
Calcifediol
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents