Effects of L-carnitine on Hypothyroidism

What Was Tested

In this phase 4 trial, researchers set out to test L-Carnitine.

L-carnitine and thyroid hormone tended to antagonize reciprocally in human body.

It had two arms (groups): L-carnitine (active comparator) and Placebo (placebo comparator).

Placebo drug, 3 tablet twice daily.

The registry classes the interventions as drug.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 20 years up to 70 years.

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

Examples of who could join: Clinical diagnosis of hypothyroidism with fatigue symptom. Currently use of the same amount of levothyroxine over at least six months. Normal serum free T4 level.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: current smoker; history of large amount of alcohol consumption; uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmhg) or diastolic blood pressure ≥ 100 mmhg.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

The L-Carnitine group and the comparison group ran side by side rather than switching.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-08 with completion listed for 2013-06.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fatigue Severity scale (time frame: baseline and 12 weeks).

It also tracked 1 secondary outcome, for example Wessely and Powell score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of L-Carnitine in 60 people.

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.