Study Stopped
Older participants could not tolerate the acidity of the product and withdrew.
Effect of Acetyl-L-carnitine on Chronic Pancreatitis
Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMarch 10, 2017
March 1, 2017
1.2 years
August 26, 2015
March 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score
McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level
3 months
Secondary Outcomes (4)
Well Being
3 months
Generalized anxiety disorder 7-item (GAD-7) Scoring
3 months
Patient Depression Questionnaire Scoring
3 months
Inflammatory Markers
3 months
Study Arms (1)
Treatment
EXPERIMENTALAcetyl-L-carnitine 1000mg 2X per day for 3 months
Interventions
non-essential dietary amino acid
Eligibility Criteria
You may qualify if:
- Only patients with chronic pancreatitis are included.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karin Highlead
- University of Kentuckycollaborator
Study Sites (1)
University of Kentucky Center for Clinical and Translational Science
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karin W High, PhD
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 26, 2015
First Posted
September 2, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
March 10, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
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