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Effect of Acetyl-L-carnitine on Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT02538146
Recruitment Status : Terminated (Older participants could not tolerate the acidity of the product and withdrew.)
First Posted : September 2, 2015
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Karin High, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Dietary Supplement: acetyl-L-carnitine 1000mg 2X per day for 3 months Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis
Study Start Date : August 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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 Name: ALC




Primary Outcome Measures :
  1. Pain score [ Time Frame: 3 months ]
    McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level


Secondary Outcome Measures :
  1. Well Being [ Time Frame: 3 months ]
    Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy

  2. Generalized anxiety disorder 7-item (GAD-7) Scoring [ Time Frame: 3 months ]
    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. Patient Depression Questionnaire Scoring [ Time Frame: 3 months ]
    5-<10 Mild Depression; 10-<15 Moderate Depression; 15-<20 Moderately Severe Depression; >20 Severe Depression

  4. Inflammatory Markers [ Time Frame: 3 months ]
    TBARS: in fasted (8 hrs) 4.7±0.2 μmol/l blood serum; TGFbeta1: 20-50 pg/ml; PDGF: 20-30 pg/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538146


Locations
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United States, Kentucky
University of Kentucky Center for Clinical and Translational Science
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Karin High
University of Kentucky
Investigators
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Principal Investigator: Karin W High, PhD University of Kentucky

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Responsible Party: Karin High, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02538146     History of Changes
Other Study ID Numbers: UKentucky
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Keywords provided by Karin High, University of Kentucky:
pain
depression
cytokines
well-being
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Acetylcarnitine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Nootropic Agents