Intermittent ClaudicationPhase 3FISHTICNCT02152930
The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
A Phase 3 study testing Omega-3 fatty acids in people with Intermittent Claudication, run by Medical Center Alkmaar at 1 site in Netherlands.
Trial summary
Intermittent claudication (IC) is caused by peripheral arterial disease and has a high morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease. Primary treatment consists of cardiovascular risk management and improvement of functional capacity with supervised exercise therapy (SET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Omega-3 fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Feb 2016
- Phase
- Phase 3
- 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
- Age ≥ 18
- Newly diagnosed intermittent claudication
- Ankle Brachial Index < 0.8 at rest or > 0.15 decrease after exercise
- Able to perform standardised treadmill walking test for 2 min
- Written informed consent
Who cannot join
- Unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the Dutch language)
- Heart failure or unstable cardiac status (angina pectoris class III or IV or recent myocardial infarction < 3 months)
- Any illness with rapid evolution or a life expectancy < 3 months
- Recent cerebrovascular accident (< 3 months)
- Current use of fish oil supplements or > 2 times a week dietary fish
- Pregnancy
Show all 9Show fewer
- Fish, soybean or peanut allergy
- Contra indications for the use of omega-3 fatty acids
- Use of oral anticoagulants (coumarin derivatives)
Trial locations and contacts
1 site in 1 country.
About this study
Intermittent claudication (IC) is caused by peripheral arterial disease and has a high morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease. Primary treatment consists of cardiovascular risk management and improvement of functional capacity with supervised exercise therapy (SET). A potential additional therapy is the administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved hemorheological parameters such as erythrocyte deformability and aggregation, and a number of cardiovascular risk factors. Hemorheological parameters determine the blood flow in the microcirculation, which is of main importance in patients with IC since the macrocirculation is compromised. Inflammation is considered an important etiologic factor in the pathogenesis of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also have a strong anti-inflammatory effect, they might be effective in patients with IC by lowering the inflammatory response. In addition, visceral fat rather than obesity in general has been recognised as an etiologic and prognostic factor in atherosclerosis.
We hypothesise that the administration of omega-3 PUFA's in patients with IC has a synergistic effect with SET and improves walking distance after SET, by improving hemorheological parameters resulting in a better microcirculation. Second, we hypothesise that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a decrease in visceral fat mass.
- Conditions
- Intermittent Claudication
- Being tested
- Omega-3 fatty acids
- Keywords
- Fish oil supplements, Supervised Exercise Training, Walking distance, Hemorheological factors, Cardiovascular risk
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDrug
Also called Fish oil supplements
1000 mg of omega-3 fatty acid ethylesters, 2 times daily, for 4 weeks, followed by 12 weeks of supervised exercise therapy in combination with 2 times daily omega-3 fatty acid supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Therapy | Active comparator | Standard treatment: Supervised Exercise Therapy during 12 weeks Receives: Drug: Omega-3 fatty acids |
| Controlled group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal walking distance with standardised treadmill test
Measured: After 12 weeks of supervised exercise therapy
Secondary outcomes (4)
Hemorheological parameters
Measured: After 12 weeks of supervised exercise therapy
Visceral fat mass
Measured: After 12 weeks of supervised exercise therapy
Ex vivo cytokine production after stimulation with lipopolysaccharide
Measured: After 12 weeks of supervised exercise therapy
Assessment of the microcirculation with side stream dark field technology
Measured: After 12 weeks of supervised exercise therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander P.J. Houdijk, Medical Center Alkmaar
- Investigators
- Alexander P.J. Houdijk, Dr., Principal investigator, Medical Center Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152930
- Sponsor's protocol ID
- NL46719.029.13
- Acronym
- FISHTIC
- Status last verified
- Jul 2018
- First submitted
- 28 May 2014
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT02152930
- Acronym / sponsor ID
- FISHTIC / NL46719.029.13
- Conditions
- Intermittent Claudication
- Keywords
- Fish oil supplements, Supervised Exercise Training, Walking distance, Hemorheological factors, Cardiovascular risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Jun 2014 (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.
Intermittent claudication (IC) is caused by peripheral arterial disease and has a high morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease. Primary treatment consists of cardiovascular risk management and improvement of functional capacity with supervised exercise therapy (SET). A potential additional therapy is the administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved hemorheological parameters such as erythrocyte deformability and aggregation, and a number of cardiovascular risk factors. Hemorheological parameters determine the blood flow in the microcirculation, which is of main importance in patients with IC since the macrocirculation is compromised. Inflammation is considered an important etiologic factor in the pathogenesis of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also have a strong anti-inflammatory effect, they might be effective in patients with IC by lowering the inflammatory response. In addition, visceral fat rather than obesity in general has been recognised as an etiologic and prognostic factor in atherosclerosis.
We hypothesise that the administration of omega-3 PUFA's in patients with IC has a synergistic effect with SET and improves walking distance after SET, by improving hemorheological parameters resulting in a better microcirculation. Second, we hypothesise that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a decrease in visceral fat mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Therapy | Active comparator | Drug: Omega-3 fatty acidsStandard treatment: Supervised Exercise Therapy during 12 weeks |
| Controlled group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Newly diagnosed intermittent claudication
- Ankle Brachial Index < 0.8 at rest or > 0.15 decrease after exercise
- Able to perform standardised treadmill walking test for 2 min
- Written informed consent
Key exclusion criteria (9 listed)
- Unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the Dutch language)
- Heart failure or unstable cardiac status (angina pectoris class III or IV or recent myocardial infarction < 3 months)
- Any illness with rapid evolution or a life expectancy < 3 months
- Recent cerebrovascular accident (< 3 months)
- Current use of fish oil supplements or > 2 times a week dietary fish
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 |
|---|---|---|
| Omega-3 fatty acidsAlso: Fish oil supplements1000 mg of omega-3 fatty acid ethylesters, 2 times daily, for 4 weeks, followed by 12 weeks of supervised exercise therapy in combination with 2 times daily omega-3 fatty acid supplementation. | Drug | Supervised Exercise Therapy |
Primary outcome
Maximal walking distance with standardised treadmill test
Time frame: After 12 weeks of supervised exercise therapy
4 secondary outcomes
Hemorheological parameters
Time frame: After 12 weeks of supervised exercise therapy
Visceral fat mass
Time frame: After 12 weeks of supervised exercise therapy
Ex vivo cytokine production after stimulation with lipopolysaccharide
Time frame: After 12 weeks of supervised exercise therapy
Assessment of the microcirculation with side stream dark field technology
Time frame: After 12 weeks of supervised exercise therapy
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
Related trials for Intermittent Claudication
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Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
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Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Improving Mobility After Revascularization in Peripheral Artery Disease
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Peripheral Artery Disease, Claudication, Intermittent
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.
Alexander P.J. Houdijk, Dr. principal investigator
Medical Center Alkmaar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 fatty acids in people with Intermittent Claudication, run by Medical Center Alkmaar at 1 site in Netherlands.
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 9 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: stopped early, as of the sponsor's last update on 31 Jul 2018. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
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?
Maximal walking distance with standardised treadmill test (time frame: After 12 weeks of supervised exercise therapy). 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 31 Jul 2018.