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

June 6, 2013 updated by: Neil Boudville, Sir Charles Gairdner Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life with KDQOL
Time Frame: Baseline, 3 & 6 months
Baseline, 3 & 6 months
Quadriceps Strength
Time Frame: Baseline, 3 & 6 months
Baseline, 3 & 6 months
Serum phosphate
Time Frame: baselibe, 3 & 6 months
baselibe, 3 & 6 months
Feeling thermometer
Time Frame: Baseline, 3 & 6 months
Baseline, 3 & 6 months
Timed up and go
Time Frame: baseline, 3 & 6 months
baseline, 3 & 6 months
Falls
Time Frame: continuous
continuous
Pulse wave velocity
Time Frame: baseline, 3 & 6 months
baseline, 3 & 6 months
Bioimpedance
Time Frame: Baseline, 3 & 6 months
Baseline, 3 & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Charles Gairdner Hospital

Investigators

  • Principal Investigator: Ben Bull, Sir Charles Gairdner Hospital
  • Study Director: Neil Boudville, Sir Charles Gairdner Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (Estimate)

November 27, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCGH25OHD2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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