NCT03008356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

December 28, 2016

Last Update Submit

January 21, 2019

Conditions

CopdFatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, end of 8 week intervention

Secondary Outcomes (3)

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

    baseline, end of 8 week intervention

  • Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11)

    baseline, end of 8 week intervention

  • Physical Activity as Measured by the SenseWear Armband

    end of 8 week intervention

Study Arms (3)

L-carnitine

EXPERIMENTAL

Oral L-carnitine 1000mg twice daily

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

Dietary Supplement: L-carnitine 1000 mg twice dailyBehavioral: Weekly health coaching calls

Placebo

PLACEBO COMPARATOR

Placebo capsules twice daily

Dietary Supplement: Placebo capsules

Interventions

L-carnitine 1000 mg twice dailyDIETARY_SUPPLEMENT

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

L-carnitineL-carnitine + health coaching
Weekly health coaching callsBEHAVIORAL

Weekly health coaching calls lasting 10-15 minutes

L-carnitine + health coaching
Placebo capsulesDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- COPD patients with a positive screen for fatigue

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveFatigue

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Roberto P Benzo

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 2, 2017

Study Start

January 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)