Effect of Acetyl-L-carnitine on Chronic Pancreatitis
Primary Purpose
Chronic Pancreatitis
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
acetyl-L-carnitine 1000mg 2X per day for 3 months
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pancreatitis focused on measuring pain, depression, cytokines, well-being
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.
Sites / Locations
- University of Kentucky Center for Clinical and Translational Science
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Acetyl-L-carnitine 1000mg 2X per day for 3 months
Outcomes
Primary Outcome Measures
Pain score
McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level
Secondary Outcome Measures
Well Being
Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy
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
Patient Depression Questionnaire Scoring
5-<10 Mild Depression; 10-<15 Moderate Depression; 15-<20 Moderately Severe Depression; >20 Severe Depression
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
Full Information
NCT ID
NCT02538146
First Posted
August 26, 2015
Last Updated
March 7, 2017
Sponsor
Karin High
Collaborators
University of Kentucky
1. Study Identification
Unique Protocol Identification Number
NCT02538146
Brief Title
Effect of Acetyl-L-carnitine on Chronic Pancreatitis
Official Title
Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Older participants could not tolerate the acidity of the product and withdrew.
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karin High
Collaborators
University of Kentucky
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
pain, depression, cytokines, well-being
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Acetyl-L-carnitine 1000mg 2X per day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
acetyl-L-carnitine 1000mg 2X per day for 3 months
Other Intervention Name(s)
ALC
Intervention Description
non-essential dietary amino acid
Primary Outcome Measure Information:
Title
Pain score
Description
McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Well Being
Description
Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy
Time Frame
3 months
Title
Generalized anxiety disorder 7-item (GAD-7) Scoring
Description
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
Time Frame
3 months
Title
Patient Depression Questionnaire Scoring
Description
5-<10 Mild Depression; 10-<15 Moderate Depression; 15-<20 Moderately Severe Depression; >20 Severe Depression
Time Frame
3 months
Title
Inflammatory Markers
Description
TBARS: in fasted (8 hrs) 4.7±0.2 μmol/l blood serum; TGFbeta1: 20-50 pg/ml; PDGF: 20-30 pg/ml
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin W High, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Center for Clinical and Translational Science
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Effect of Acetyl-L-carnitine on Chronic Pancreatitis
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