End Stage Kidney DiseasePhase 4NCT00798993
Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients
A Phase 4 study testing Structured Exercise program, Cholecalciferol (25-Hydroxyvitamin D) and Usual exercise in people with End Stage Kidney Disease, run by Sir Charles Gairdner Hospital at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Structured Exercise program, Cholecalciferol (25-Hydroxyvitamin D) and Usual exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2009to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
About this study
Official title: 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.
- Conditions
- End Stage Kidney Disease
- Being tested
- Structured Exercise program, Cholecalciferol (25-Hydroxyvitamin D), Usual exercise
- Keywords
- Chronic kidney failure, 25 hydroxyvitamin D, falls, exercise, quadriceps strength
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise programOther
30 minutes on an exercise bicycle during every dialysis
Cholecalciferol (25-Hydroxyvitamin D)Drug
Cholecalciferol 2000U per day will be given for duration of study to all participants
Usual exerciseOther
Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months
| Study group | Role | What they receive |
|---|---|---|
| Structured exercise program | Active comparator | Participants will be randomised at 3 months into either this group or the comparator of usual exercise. Receives: Other: Structured Exercise program |
| Vitamin D | Experimental | Cholecalciferol 2000U per day will be given to all participants for the duration of the study Receives: Drug: Cholecalciferol (25-Hydroxyvitamin D) |
| Usual exercise | Placebo comparator | Participants randomised to this arm, at 3 months, will continue on their usual exercise routine Receives: Other: Usual exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity - modified shuttle walk test
Measured: Basesline, 3 & 6 months
Secondary outcomes (8)
Quality of life with KDQOL
Measured: Baseline, 3 & 6 months
Quadriceps Strength
Measured: Baseline, 3 & 6 months
Serum phosphate
Measured: baselibe, 3 & 6 months
Feeling thermometer
Measured: Baseline, 3 & 6 months
Timed up and go
Measured: baseline, 3 & 6 months
Falls
Measured: continuous
Pulse wave velocity
Measured: baseline, 3 & 6 months
Bioimpedance
Measured: Baseline, 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Charles Gairdner Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Boudville, Sir Charles Gairdner Hospital
- Investigators
- Ben Bull, Principal investigator, Sir Charles Gairdner HospitalNeil Boudville, Study director, Sir Charles Gairdner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798993
- Sponsor's protocol ID
- SCGH25OHD2008
- Status last verified
- Jun 2013
- First submitted
- 26 Nov 2008
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients
- ClinicalTrials.gov ID
- NCT00798993
- Acronym / sponsor ID
- SCGH25OHD2008
- Conditions
- End Stage Kidney Disease
- Keywords
- Chronic kidney failure, 25 hydroxyvitamin D, falls, exercise, quadriceps strength
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sir Charles Gairdner HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structured exercise program | Active comparator | Other: Structured Exercise programParticipants will be randomised at 3 months into either this group or the comparator of usual exercise. |
| Vitamin D | Experimental | Drug: Cholecalciferol (25-Hydroxyvitamin D)Cholecalciferol 2000U per day will be given to all participants for the duration of the study |
| Usual exercise | Placebo comparator | Other: Usual exerciseParticipants randomised to this arm, at 3 months, will continue on their usual exercise routine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Limb Amputation
- Impaired cognition
- Impaired vision
- Haemoglobin concentration < 110g/L
- Change in Erythropoiesis stimulating agent dose over the last 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Exercise program30 minutes on an exercise bicycle during every dialysis | Other | Structured exercise program |
| Cholecalciferol (25-Hydroxyvitamin D)Cholecalciferol 2000U per day will be given for duration of study to all participants | Drug | Vitamin D |
| Usual exerciseParticipants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months | Other | Usual exercise |
Primary outcome
Exercise capacity - modified shuttle walk test
Time frame: Basesline, 3 & 6 months
8 secondary outcomes
Quality of life with KDQOL
Time frame: Baseline, 3 & 6 months
Quadriceps Strength
Time frame: Baseline, 3 & 6 months
Serum phosphate
Time frame: baselibe, 3 & 6 months
Feeling thermometer
Time frame: Baseline, 3 & 6 months
Timed up and go
Time frame: baseline, 3 & 6 months
Falls
Time frame: continuous
Pulse wave velocity
Time frame: baseline, 3 & 6 months
Bioimpedance
Time frame: Baseline, 3 & 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Bull principal investigator
Sir Charles Gairdner Hospital
Neil Boudville study director
Sir Charles Gairdner Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Structured Exercise program, Cholecalciferol (25-Hydroxyvitamin D) and Usual exercise in people with End Stage Kidney Disease, run by Sir Charles Gairdner Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity - modified shuttle walk test (time frame: Basesline, 3 & 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.