L-carnitine for Fatigue in COPD

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test L-Carnitine.

It had three arms (groups): L-carnitine (experimental), L-carnitine + health coaching (experimental) and Placebo (placebo comparator).

Placebo capsules twice daily.

The registry classes the interventions as behavioral and dietary supplement.

Who Took Part

33 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 11 exclusion criteria; among the exclusions: vulnerable population - pregnant women, prisoners, unable to provide consent; pre-menopausal/breastfeeding women (pregnancy category b); thyroid disease.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-01 with completion listed for 2018-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT) (time frame: baseline, end of 8 week intervention).

It also tracked 3 secondary outcomes, for example Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ), Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11) and Physical Activity as Measured by the SenseWear Armband.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of L-Carnitine in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.