Effect of Acetyl-L-carnitine on Chronic Pancreatitis

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Brief Title

Effect of Acetyl-L-carnitine on Chronic Pancreatitis

Official Title

Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis

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.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Pain score

Secondary Outcome

 Well Being

Condition

Chronic Pancreatitis

Intervention

acetyl-L-carnitine 1000mg 2X per day for 3 months

Study Arms / Comparison Groups

 Treatment
Description:  Acetyl-L-carnitine 1000mg 2X per day for 3 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

3

Start Date

August 2015

Completion Date

October 2016

Primary Completion Date

October 2016

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.
      

Gender

All

Ages

20 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Karin W High, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02538146

Organization ID

UKentucky


Responsible Party

Sponsor-Investigator

Study Sponsor

Karin High

Collaborators

 University of Kentucky

Study Sponsor

Karin W High, PhD, Principal Investigator, University of Kentucky


Verification Date

March 2017