Effect of Acetyl-L-carnitine on Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02538146
• Other study ID #: UKentucky
• Status: Terminated
• Phase: Early Phase 1
• First received: August 26, 2015
• Last updated: March 7, 2017
• Start date: August 2015
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Dietary Supplement:
• acetyl-L-carnitine 1000mg 2X per day for 3 months
non-essential dietary amino acid

Locations

Country	Name	City	State
United States	University of Kentucky Center for Clinical and Translational Science	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Karin High	University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level	3 months
Secondary	Well Being	Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy	3 months
Secondary	Generalized anxiety disorder 7-item (GAD-7) Scoring	5-< 10 Mild Anxiety 10-<15 Moderate Anxiety >15 Severe Anxiety 5-< 10 Mild Anxiety 10-<15 Moderate Anxiety >15 Severe Anxiety 5-< 10 Mild Anxiety 10-<15 Moderate Anxiety >15 Severe Anxiety 5-< 10 Mild Anxiety; 10-<15 Moderate Anxiety; >15 Severe Anxiety	3 months
Secondary	Patient Depression Questionnaire Scoring	5-<10 Mild Depression; 10-<15 Moderate Depression; 15-<20 Moderately Severe Depression; >20 Severe Depression	3 months
Secondary	Inflammatory Markers	TBARS: in fasted (8 hrs) 4.7±0.2 µmol/l blood serum; TGFbeta1: 20-50 pg/ml; PDGF: 20-30 pg/ml	3 months