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LC4COPD: L-carnitine for Fatigue in COPD

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03008356
Collaborator
(none)
33
Enrollment
1
Location
3
Arms
13
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

based on our review of literature that addition of health coaching (HC) to L-carnitine will yield greater gains.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: L-carnitine 1000 mg twice daily
  • Behavioral: Weekly health coaching calls
  • Dietary Supplement: Placebo capsules
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Feb 1, 2018
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: L-carnitine

Oral L-carnitine 1000mg twice daily

Dietary Supplement: L-carnitine 1000 mg twice daily
Oral L-carnitine to be taken twice daily for 8 weeks
Experimental: L-carnitine + health coaching

Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls

Dietary Supplement: L-carnitine 1000 mg twice daily
Oral L-carnitine to be taken twice daily for 8 weeks

Behavioral: Weekly health coaching calls
Weekly health coaching calls lasting 10-15 minutes
Placebo Comparator: Placebo

Placebo capsules twice daily

Dietary Supplement: Placebo capsules

Outcome Measures

Primary Outcome Measures

  1. Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT) [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.

Secondary Outcome Measures

  1. Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ) [baseline, end of 8 week intervention]

    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.

  2. Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11) [baseline, end of 8 week intervention]

    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.

  3. Physical Activity as Measured by the SenseWear Armband [end of 8 week intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
  • COPD patients with a positive screen for fatigue
Exclusion criteria:

  • 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)

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Roberto P Benzo, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roberto P. Benzo, PI, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03008356
Other Study ID Numbers:
  • 16-005732
First Posted:
Jan 2, 2017
Last Update Posted:
Jan 23, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Fatigue

Study Results

No Results Posted as of Jan 23, 2019