Propionyl-L-Carnitine in Ulcerative Colitis

What Was Tested

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

The purpose of this study is to determine whether Propionyl-L-carnitine administration may ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in treatment with one of the standard treatments (corticosteroids excluded).

It had three arms (groups): one (experimental), one (experimental) and one (placebo comparator).

40 patients each arm.

40 patients each arm.

40 patients each arm.

The registry classes the interventions as drug.

Who Took Part

121 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Have read the Information for the Patient and signed the Informed Consent Form. Age comprised between 18 and 75 included. If female, not pregnant or nursing. Availability of a pancolonoscopy and histology both confirming the diagnosis of active ulcerative colitis. Disease Activity Index comprised between 3 and 10, inclusive, (mild to moderate ulcerative colitis).

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: first diagnosis of ulcerative colitis; crohn's disease; current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.

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.

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 and investigator.

It started in 2006-05 with completion listed for 2009-04.

It ran at 15 sites in Italy (5), Russia (5), Poland (3) and Lithuania (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Disease Activity Index score (time frame: baseline, week 4).

It also tracked 1 secondary outcome, for example Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 121 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.