L-Carnitine to Treat Fatigue in AIDS Patients

What Was Tested

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

Patients with AIDS may develop a deficiency of the micronutrient carnitine and such a deficiency may contribute to fatigue in these patients.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Fatigue is a commonly reported symptom in patients with end stage AIDS.

The role of progression of the disease, depression, anemia, and poor nutritional status in the development of fatigue is well recognized.

However, the impact of micronutrient deficiencies has been minimally explored.

Patients with AIDS are particularly likely to be carnitine deficient.

Who Took Part

The registry lists 44 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.

Examples of who could join: AIDS at Stage IV-C and estimated life expectancy \< 6 months. Karnofsky Performance Score \> 50. If undergoing pre-existing treatment for fatigue, must have been on a stable regimen for at least 4 weeks prior to study entry.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: severe cardiovascular, pulmonary, or renal function; treatment or replacement therapy with any form of carnitine within 12 months prior to study entry; known sensitivity to carnitine.

How the Study Was Run

Design: 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.

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, investigator and outcomes assessor.

It started in 2002-11 with completion listed for 2007-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Level of fatigue, measured by the fatigue sub-scale of the FAHI (time frame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination)).

It also tracked 2 secondary outcomes, for example Changes in fatigue in the treatment and control groups and Changes in cognative status, mood, activity, and HGB levels mesured by BFI, LASA, KPS, and MSAS-SF.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 44 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.