Effect of Acetyl-L-carnitine on Chronic Pancreatitis

Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Dietary supplement: acetyl-L-carnitine 1000mg 2X per day for 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Center for Clinical and Translational Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Acetyl-L-carnitine 1000mg 2X per day for 3 months	Dietary supplement: acetyl-L-carnitine 1000mg 2X per day for 3 months; non-essential dietary amino acid; Other Names: ALC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well Being	Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy	3 months
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
Patient Depression Questionnaire Scoring	5-<10 Mild Depression; 10-<15 Moderate Depression; 15-<20 Moderately Severe Depression; >20 Severe Depression	3 months
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

Collaborators and Investigators

• Sponsor: Karin High
• Collaborators: University of Kentucky
• Investigators: Principal Investigator: Karin W High, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: pain; depression; well-being; cytokines
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Nootropic Agents; Acetylcarnitine
• Other Study ID Numbers: UKentucky

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: One young participant (>35) successfully completed the trial and provided a personal statement and data indicating the acetyl-L-carnatine had improved his pancreatitis. Two older individuals (>60) withdrew from the study within two months citing inability to tolerate the acidity of the product. Difficulties recruiting in this very ill population was also a consideration in termination. For additional information contact sabrina.mcilwrath@uky.edu