L-Carnitine for Fatigue in COPD
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-005732
NCT ID: NCT03008356
Sponsor Protocol Number: 16-005732
About this study
We hypothesize that 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). We further hypothesize based on our review of literature that addition of health coaching (HC) to L-carnitine will yield greater gains.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Roberto Benzo, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available