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OpenTrials
Completed

NCT Number: NCT03008356

L-carnitine for Fatigue in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-carnitine 1000 mg twice daily

Dietary Supplement

Oral L-carnitine to be taken twice daily for 8 weeks

Weekly health coaching calls

Behavioral

Weekly health coaching calls lasting 10-15 minutes

Placebo capsules

Dietary Supplement

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ)

    Time frame: 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)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Acronym: LC4COPD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2017
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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