Effect of Acetyl-L-carnitine on Chronic Pancreatitis

What Was Tested

In this early phase 1 trial, researchers set out to test L-Carnitine.

An open label pilot study will determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis.

The ALC is given to all participants for 3 months, and assessments will occur at intake and after 3 months.

It had 1 arm (groups): Treatment (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

This is an open label pilot study to determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on chronic pancreatitis.

ALC is an acetylated form of naturally occurring amino acid L-carnitine ((R)-3-Acetyloxy-4-trimethylammonio-butanoate) found in red meat and is readily commercially available.

The measurable outcomes of this clinical study are patients' questionnaire scores for: pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis.

The questionnaires are given at intake and at experiment end (3 months).

Who Took Part

The registry lists 3 actual participants took part.

It was open to people of any sex aged from 20 years up to 90 years.

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

Examples of who could join: Only patients with chronic pancreatitis are included.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: patients with pancreatic pseudocysts, abscesses, pseudoaneurysms, pancreatitic fistulas, pancreatic adenocarcinoma,; females that are pregnant or lactating; children are excluded.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-08 with completion listed for 2016-10.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Pain score (time frame: 3 months).

It also tracked 4 secondary outcomes, for example Well Being, Generalized anxiety disorder 7-item (GAD-7) Scoring, Patient Depression Questionnaire Scoring and Inflammatory Markers.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of L-Carnitine in 3 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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