End Stage Renal DiseasePhase 2NCT00179179
The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis
A Phase 2 study testing nutritional supplementation and exercise in people with End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- nutritional supplementation and exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to May 2007
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program.
- Adequately dialyzed (Kt/V > 1.2).
- Age 18-75
Who cannot join
- Pregnant women.
- Patients unable to perform exercise
- Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
- Patients hospitalized within the last month prior to the study.
- Patients with malfunctioning arterial-venous access (recirculation and/or blood flow < 750 ml/min)
- Patients receiving steroids and/or other immunosuppressive agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session.
- Conditions
- End Stage Renal Disease
- Being tested
- nutritional supplementation, exercise
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional supplementationDrug
2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period
exerciseBehavioural
resistance training on a duel leg press consisting of 3 sets of 8-12 repetitions; the first 5 study visits over a 12-month period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | nutritional supplement plus resistance exercise Receives: Drug: nutritional supplementation; Behavioral: exercise |
| 2 | Active comparator | nutritional supplement only (resistance exercise will not be performed) Receives: Drug: nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in net protein muscle balance
Measured: 10 hours
Secondary outcomes (1)
improvement in net whole body protein balance
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Alp Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179179
- Sponsor's protocol ID
- 50189
- Other IDs
- R01DK045604
- Status last verified
- Jul 2009
- First submitted
- 13 Sep 2005
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis
- ClinicalTrials.gov ID
- NCT00179179
- Acronym / sponsor ID
- 50189
- Conditions
- End Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 15 Sep 2005 (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.
To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: nutritional supplementation, Behavioral: exercisenutritional supplement plus resistance exercise |
| 2 | Active comparator | Drug: nutritional supplementationnutritional supplement only (resistance exercise will not be performed) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program.
- Adequately dialyzed (Kt/V > 1.2).
- Age 18-75
Key exclusion criteria (6 listed)
- Pregnant women.
- Patients unable to perform exercise
- Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
- Patients hospitalized within the last month prior to the study.
- Patients with malfunctioning arterial-venous access (recirculation and/or blood flow < 750 ml/min)
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 |
|---|---|---|
| nutritional supplementation2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period | Drug | 1, 2 |
| exerciseresistance training on a duel leg press consisting of 3 sets of 8-12 repetitions; the first 5 study visits over a 12-month period | Behavioural | 1 |
Primary outcome
improvement in net protein muscle balance
Time frame: 10 hours
1 secondary outcome
improvement in net whole body protein balance
Time frame: 10 hours
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 9 Jul 2009.
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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.
Alp Ikizler, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nutritional supplementation and exercise in people with End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
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 3 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 9 Jul 2009. 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
improvement in net protein muscle balance (time frame: 10 hours). 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 9 Jul 2009.