End Stage Renal DiseasePhase 2NCT00655525
Omega-3 Fatty Acid Administration in Dialysis Patients
A Phase 2 study testing fish oil in people with End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The overall goal of this study is to examine the role of fish oil supplementation in ameliorating the inflammatory state of uremia and the related muscle protein catabolism associated with this disease state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on CHD for more than 6 months;
- Ability to read and sign the consent form;
- Have acceptable dialysis adequacy (Kt/V > 1.2);
- Use biocompatible hemodialysis membrane;
- Have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
- Signs of chronic inflammation (average CRP of ≥ 5 mg/L for 3 consecutive measurements)
Who cannot join
- Pregnancy;
- Intolerance to the study medication;
- Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
- Diabetes mellitus on insulin therapy;
- Hospitalization within 1 month prior to the study;
- Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 500 ml/min);
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- Patients receiving steroids (> 5 mg/day) and/or other immunosuppressive agents;
- Life-expectancy less than 6 months;
- Age less than 18 years old;
- Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
- Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The overall goal of this study is to examine the role of fish oil supplementation in ameliorating the inflammatory state of uremia and the related muscle protein catabolism associated with this disease state. We hypothesize that if administered for a period of 3 months, fish oil will improve the chronic uremic inflammation. We further hypothesize that fish oil administration will improve the muscle protein breakdown associated with uremia and inflammation.
- Conditions
- End Stage Renal Disease
- Being tested
- fish oil, placebo
- Keywords
- inflammation, end stage renal disease
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDietary supplement
Also called eicosapentaenoic acid/docosahexaenoic acid
2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months
placeboDietary supplement
placebo administered orally every day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Dietary Supplement: fish oil |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)
Measured: 3 months
A decrease in muscle protein breakdown
Measured: 3 months
Secondary outcomes (2)
A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)
Measured: 3 months
An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionJun 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ikizler, Vanderbilt University
- Investigators
- Alp Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655525
- Sponsor's protocol ID
- 080191
- Other IDs
- R21AT003844-01A2
- Status last verified
- Apr 2014
- First submitted
- 4 Apr 2008
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Administration in Dialysis Patients
- ClinicalTrials.gov ID
- NCT00655525
- Acronym / sponsor ID
- 080191
- Conditions
- End Stage Renal Disease
- Keywords
- inflammation, end stage renal disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Apr 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.
The overall goal of this study is to examine the role of fish oil supplementation in ameliorating the inflammatory state of uremia and the related muscle protein catabolism associated with this disease state. We hypothesize that if administered for a period of 3 months, fish oil will improve the chronic uremic inflammation. We further hypothesize that fish oil administration will improve the muscle protein breakdown associated with uremia and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: fish oil |
| 2 | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients on CHD for more than 6 months;
- Ability to read and sign the consent form;
- Have acceptable dialysis adequacy (Kt/V > 1.2);
- Use biocompatible hemodialysis membrane;
- Have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
Key exclusion criteria (11 listed)
- Pregnancy;
- Intolerance to the study medication;
- Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
- Diabetes mellitus on insulin therapy;
- Hospitalization within 1 month prior to the study;
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 |
|---|---|---|
| fish oilAlso: eicosapentaenoic acid/docosahexaenoic acid2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months | Dietary supplement | 1 |
| placeboplacebo administered orally every day for 3 months | Dietary supplement | 2 |
Primary outcome
A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)
Time frame: 3 months
A decrease in muscle protein breakdown
Time frame: 3 months
2 secondary outcomes
A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)
Time frame: 3 months
An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)
Time frame: 3 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 23 Apr 2014.
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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 fish oil 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 6 inclusion and 11 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 23 Apr 2014. 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. 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 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?
A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 23 Apr 2014.