Chronic PancreatitisEarly Phase 1NCT02538146
Effect of Acetyl-L-carnitine on Chronic Pancreatitis
A Early Phase 1 study testing acetyl-L-carnitine 1000mg 2X per day for 3 months in people with Chronic Pancreatitis, run by Karin High at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- acetyl-L-carnitine 1000mg 2X per day for 3 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Oct 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only patients with chronic pancreatitis are included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Center for Clinical and Translational Science
Lexington, Kentucky, 40536
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- acetyl-L-carnitine 1000mg 2X per day for 3 months
- Keywords
- pain, depression, cytokines, well-being
- Medical subject headings
- Pancreatitis, Chronic, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetyl-L-carnitine 1000mg 2X per day for 3 monthsDietary supplement
Also called ALC
non-essential dietary amino acid
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Acetyl-L-carnitine 1000mg 2X per day for 3 months Receives: Dietary Supplement: acetyl-L-carnitine 1000mg 2X per day for 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level
Measured: 3 months
Secondary outcomes (4)
Well Being
Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy
Measured: 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
Measured: 3 months
Patient Depression Questionnaire Scoring
5-<10 Mild Depression; 10-<15 Moderate Depression; 15-<20 Moderately Severe Depression; >20 Severe Depression
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Older participants could not tolerate the acidity of the product and withdrew.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karin High
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor-investigator, Karin High, University of Kentucky
- Investigators
- Karin W High, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538146
- Sponsor's protocol ID
- UKentucky
- Status last verified
- Mar 2017
- First submitted
- 26 Aug 2015
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT02538146
- Acronym / sponsor ID
- UKentucky
- Conditions
- Chronic Pancreatitis
- Keywords
- pain, depression, cytokines, well-being
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Older participants could not tolerate the acidity of the product and withdrew.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Karin HighUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: acetyl-L-carnitine 1000mg 2X per day for 3 monthsAcetyl-L-carnitine 1000mg 2X per day for 3 months |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only patients with chronic pancreatitis are included.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetyl-L-carnitine 1000mg 2X per day for 3 monthsAlso: ALCnon-essential dietary amino acid | Dietary supplement | Treatment |
Primary outcome
Pain score
Time frame: 3 months
McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level
4 secondary outcomes
Well Being
Time frame: 3 months
Generalized anxiety disorder 7-item (GAD-7) Scoring
Time frame: 3 months
Patient Depression Questionnaire Scoring
Time frame: 3 months
Inflammatory Markers
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Older participants could not tolerate the acidity of the product and withdrew.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: Yes. 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
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin W High, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing acetyl-L-carnitine 1000mg 2X per day for 3 months in people with Chronic Pancreatitis, run by Karin High at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Older participants could not tolerate the acidity of the product and withdrew.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.