L-carnitine for Fatigue in COPD (LC4COPD)

Mayo Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Copd; Fatigue

Treatments: Dietary Supplement: Placebo capsules; Dietary Supplement: L-carnitine 1000 mg twice daily; Behavioral: Weekly health coaching calls

Study type: Interventional

Funder types: Other

Identifiers

NCT03008356

16-005732

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups, including a placebo group

L-carnitine

Experimental group

Description:

Oral L-carnitine 1000mg twice daily

Treatment:

Dietary Supplement: L-carnitine 1000 mg twice daily

L-carnitine + health coaching

Experimental group

Description:

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

Treatment:

Dietary Supplement: L-carnitine 1000 mg twice daily

Behavioral: Weekly health coaching calls

Placebo

Placebo Comparator group

Description:

Placebo capsules twice daily

Treatment:

Dietary Supplement: Placebo capsules