CopdPhase 2/3LC4COPDNCT03008356
L-carnitine for Fatigue in COPD
A Phase 2/3 study testing L-carnitine 1000 mg twice daily and Weekly health coaching calls in people with Copd and Fatigue, run by Mayo Clinic at 1 site in United States.
Trial summary
supplementation with L-carnitine that is available both as an FDA-approved therapy for primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires in patient with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- L-carnitine 1000 mg twice daily and Weekly health coaching calls
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Feb 2018
- Phase
- Phase 2/3
- 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
- COPD patients with a positive screen for fatigue
Who cannot join
- Vulnerable population - pregnant women, prisoners, unable to provide consent
- Pre-menopausal/breastfeeding women (pregnancy category B)
- Thyroid disease
- Anticoagulation therapy
- Decompensated cardiac disease
- Chronic Kidney Disease (CKD4 or above)
Show all 11Show fewer
- Known seizure disorder
- Active malignancy
- Exacerbation of underlying pulmonary disease or acute illness in the 6 weeks before screening
- Enrollment in the past 6 weeks or currently in a cardiac or pulmonary rehab program or other physical fitness class(es).
- Difficulty with swallowing pills
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)
supplementation with L-carnitine that is available both as an FDA-approved therapy for primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires in patient with chronic obstructive pulmonary disease (COPD).
based on our review of literature that addition of health coaching (HC) to L-carnitine will yield greater gains.
- Being tested
- L-carnitine 1000 mg twice daily, Weekly health coaching calls, Placebo capsules
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitine 1000 mg twice dailyDietary supplement
Oral L-carnitine to be taken twice daily for 8 weeks
Weekly health coaching callsBehavioural
Weekly health coaching calls lasting 10-15 minutes
Placebo capsulesDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| L-carnitine | Experimental | Oral L-carnitine 1000mg twice daily Receives: Dietary Supplement: L-carnitine 1000 mg twice daily |
| L-carnitine + health coaching | Experimental | Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls Receives: Dietary Supplement: L-carnitine 1000 mg twice daily; Behavioral: Weekly health coaching calls |
| Placebo | Placebo comparator | Placebo capsules twice daily Receives: Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT)
The 6MWT is a widely studied, standardized and widely utilized test that evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The self-paced 6MWT assesses the submaximal level of functional capacity. Most patients do not achieve maximal exercise capacity during the 6MWT; instead, they choose their own intensity of exercise and are allowed to stop and rest during the test.
Measured: baseline, end of 8 week intervention
Secondary outcomes (3)
Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ)
The CRQ is a widely utilized and validated interviewer-administered questionnaire measuring both physical and emotional aspects of chronic respiratory disease. There are 20 questions, with each item graded on 7-point Likert scale. Scores can range from 20 to 100. Higher scores indicate better quality of life.
Measured: baseline, end of 8 week intervention
Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11)
The CFQ-11 is a well-known, widely utilized and validated self-administered questionnaire for measuring the extent and severity of fatigue. The scoring incorporates two self-assessment scales measuring components indicative of physical fatigue [8 items] and mental fatigue [5 items]. The 11 individual items are scored from 0 (better than usual) to 3 (much worse than usual); total score range: 0-33.
Measured: baseline, end of 8 week intervention
Physical Activity as Measured by the SenseWear Armband
The SenseWear Armband system (Temple Healthcare) is a versatile arm-band monitor allowing convenient and accurate collection of raw data regarding energy expenditure, sleep duration and quality, physical activity and movement in subjects in a free-living environment, allowing them to go about their normal daily activities. Patients will be shown how to wear the activity monitor and be asked to use it for at least 5 days for 23 hours a day. They will be provided instructions and pre-paid shipping materials for wear and return of the monitor.
Measured: end of 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto P Benzo, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008356
- Sponsor's protocol ID
- 16-005732
- Acronym
- LC4COPD
- Status last verified
- Jan 2019
- First submitted
- 28 Dec 2016
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03008356
- Acronym / sponsor ID
- LC4COPD / 16-005732
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 2 Jan 2017 (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.
supplementation with L-carnitine that is available both as an FDA-approved therapy for primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires in patient with chronic obstructive pulmonary disease (COPD).
based on our review of literature that addition of health coaching (HC) to L-carnitine will yield greater gains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L-carnitine | Experimental | Dietary Supplement: L-carnitine 1000 mg twice dailyOral L-carnitine 1000mg twice daily |
| L-carnitine + health coaching | Experimental | Dietary Supplement: L-carnitine 1000 mg twice daily, Behavioral: Weekly health coaching callsOral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls |
| Placebo | Placebo comparator | Dietary Supplement: Placebo capsulesPlacebo capsules twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients with a positive screen for fatigue
Key exclusion criteria (11 listed)
- Vulnerable population - pregnant women, prisoners, unable to provide consent
- Pre-menopausal/breastfeeding women (pregnancy category B)
- Thyroid disease
- Anticoagulation therapy
- Decompensated cardiac disease
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 |
|---|---|---|
| L-carnitine 1000 mg twice dailyOral L-carnitine to be taken twice daily for 8 weeks | Dietary supplement | L-carnitine, L-carnitine + health coaching |
| Weekly health coaching callsWeekly health coaching calls lasting 10-15 minutes | Behavioural | L-carnitine + health coaching |
| Placebo capsules | Dietary supplement | Placebo |
Primary outcome
Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT)
Time frame: baseline, end of 8 week intervention
The 6MWT is a widely studied, standardized and widely utilized test that evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The self-paced 6MWT assesses the submaximal level of functional capacity. Most patients do not achieve maximal exercise capacity during the 6MWT; instead, they choose their own intensity of exercise and are allowed to stop and rest during the test.
3 secondary outcomes
Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ)
Time frame: baseline, end of 8 week intervention
Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11)
Time frame: baseline, end of 8 week intervention
Physical Activity as Measured by the SenseWear Armband
Time frame: end of 8 week intervention
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 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Copd
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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.
Roberto P Benzo principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing L-carnitine 1000 mg twice daily and Weekly health coaching calls in people with Copd and Fatigue, run by Mayo Clinic 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 1 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 Jan 2019. 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 combined 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.
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 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?
Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT) (time frame: baseline, end of 8 week intervention). 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 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.