Effect of Levocarnitine Supplementation for the Management of Fatigue in Levothyroxine-Treated Hypothyroid Patients

What Was Tested

The trial (not phased) is built around L-Carnitine.

It has been observed that despite administration of apparently adequate thyroid hormone replacement in hypothyroid patients, many of them experience persistent fatigue and fatigue-related symptoms.

Carnitine transports long chain fatty acids into the mitochondria whereupon the high energy source (ATP) becomes synthesized.

It had two arms (groups): Control group (no intervention) and Intervention group (experimental).

Control group - patients with only levothyroxine therapy.

Intervention Group- Patients with levocarnitine supplementation in addition to levothyroxine therapy.

The registry classes the interventions as drug.

More on the Plan

It has been well-established now-a-days that, some chronic diseases impose generalized weakness, lethargy, lassitude amounting from degrees mild, moderate to a severe one to total incapacitation on the part of the patients.

Hypothyroid patients instate of receiving adequate thyroid hormone replacement, experience fatigue-related symptoms.

Carnitine is a non-essential amino acid synthesized endogenously from essential amino acids- lysine and methionine with in the body involved in long chain fatty acid transportation to the mitochondrial membrane.

Carnitine- transportation system is essential for production of energy at cellular level.

Who Took Part

Enrollment: 90 planned participants were the target.

It was open to people of any sex aged from 20 years up to 50 years.

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

How the Study Was Run

The set-up was randomized, parallel-group and single-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.

Only one side, usually the participants, was kept unaware of whether L-Carnitine was given.

Those kept unaware of assignments: participant.

It started in 2017-03-16 with completion listed for 2017-12-30.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fatigue score (time frame: 8 weeks).

It also tracked 1 secondary outcome, for example Lipid profile.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 90 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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