Clinical trial NCT02538146: Effect of Acetyl-L-carnitine on Chronic Pancreatitis
Official title: Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Chronic Pancreatitis
Keywords: pain
depression
cytokines
well-being
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2015-09-02
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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. Supplementation with ALC may decrease pain and improve overall health based on our preclinical treatment studies in rats with high fat and alcohol induced pancreatitis. In rats, ALC reduces pain measures, improves glucose tolerance, decreases lipid peroxidation, and Ki67 cellular injury biomarker, and improves pancreatic histopathology. 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). Participants will receive ALC for 3 months. These findings will indirectly determine the effect of ALC on the function and inflammatory state of the pancreas. Currently, there is no specific therapy for chronic pancreatitis, and its pathophysiology is still poorly understood. It is known that chronic pancreatitis is caused by ongoing inflammation in the pancreas, yet, no pharmacological intervention exists that optimally addresses this. The broad actions of ALC as an antioxidant and anti-inflammatory agent as well as its ability to reduce side-effects of alcohol cessation make it a perfect compound to pursue for the treatment of pancreatitis.

Eligibility criteria: Inclusion Criteria:

* Only patients with chronic pancreatitis are included.

Exclusion Criteria:

* Patients with pancreatic pseudocysts, abscesses, pseudoaneurysms, pancreatitic fistulas, pancreatic adenocarcinoma,
* Females that are pregnant or lactating
* Children are excluded.
* Patients suffering from seizure or thyroid disorders are also excluded due to possible exaggeration of their symptoms from taking ALC according to manufacturer.

Primary outcomes:
measure: Pain score
timeFrame: 3 months
Secondary outcomes:
measure: Well Being
timeFrame: 3 months
measure: Generalized anxiety disorder 7-item (GAD-7) Scoring
timeFrame: 3 months
measure: Patient Depression Questionnaire Scoring
timeFrame: 3 months
measure: Inflammatory Markers
timeFrame: 3 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Center for Clinical and Translational Science
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Karin W High, PhD
role: PRINCIPAL_INVESTIGATOR
References: