Ammonia MetabolismPhase 2/3NCT03021876
L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients
A Phase 2/3 study testing L-carnitine and usual intake in people with Ammonia Metabolism, run by Kochi University at 1 site in Japan.
Trial summary
L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in corresponding tissues of eight normally nourished non-hepatic patients who died after an acute illness of a 1-3-day duration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ammonia Metabolism
- What is being tested?
- L-carnitine and usual intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2016to Apr 2018
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients were those surgically treated for hepato-biliary diseases
Who cannot join
- Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kochi Health Sciences Center
Kochi, Kochi, 781-0111
Takehiro Okabayashi, MD PhD, +81 88-837-3000, takehiro_okabayashi@khsc.or.jp
About this study
L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in corresponding tissues of eight normally nourished non-hepatic patients who died after an acute illness of a 1-3-day duration. In the recent years, it has been reported that sirtuin 3 (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing SIRT3 to improve mitochondrial dynamics has potential as a strategy for improving outcomes of renal injury. In the current study, it is the first clinical interventional research whether L-carnitine corrects ammonia metabolism associated with liver injury in hepatectomized patients.
- Conditions
- Ammonia Metabolism
- Being tested
- L-carnitine, usual intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDrug
Also called Carnitine group
treatment with oral L-carnitine, 1500 mg/body per day
usual intakeOther
Also called Usual group
baseliner
| Study group | Role | What they receive |
|---|---|---|
| ordinary group | Placebo comparator | usual intake prior to liver surgery Receives: Other: usual intake |
| carnitine group | Active comparator | treatment with oral L-carnitine, 1500 mg/body per day for 2 weeks prior to liver surgery Receives: Drug: L-carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative ammonia levels
change from preoperative baseline at postoperative day 1 and day3
Measured: 3 points; preoperative baseline, postoperative day 1, and day3
Secondary outcomes (1)
length of hospitalization after liver resection
postoperative days
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ammonia MetabolismStudies 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takehiro Okabayashi, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021876
- Sponsor's protocol ID
- LAMP study
- Status last verified
- Jan 2017
- First submitted
- 12 Mar 2016
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Okabayashi T, Sui K, Mastumoto T, Iwata J, Morita S, Iiyama T, Shimada Y. l-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients. JPEN J Parenter Enteral Nutr. 2020 Jul;44(5):823-830. doi: 10.1002/jpen.1720. Epub 2019 Oct 9.
PubMed 31599019
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients
- ClinicalTrials.gov ID
- NCT03021876
- Acronym / sponsor ID
- LAMP study
- Conditions
- Ammonia Metabolism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 16 Jan 2017 (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.
L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in corresponding tissues of eight normally nourished non-hepatic patients who died after an acute illness of a 1-3-day duration. In the recent years, it has been reported that sirtuin 3 (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing SIRT3 to improve mitochondrial dynamics has potential as a strategy for improving outcomes of renal injury. In the current study, it is the first clinical interventional research whether L-carnitine corrects ammonia metabolism associated with liver injury in hepatectomized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ordinary group | Placebo comparator | Other: usual intakeusual intake prior to liver surgery |
| carnitine group | Active comparator | Drug: L-carnitinetreatment with oral L-carnitine, 1500 mg/body per day for 2 weeks prior to liver surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients were those surgically treated for hepato-biliary diseases
Key exclusion criteria (1 listed)
- Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
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 |
|---|---|---|
| L-carnitineAlso: Carnitine grouptreatment with oral L-carnitine, 1500 mg/body per day | Drug | carnitine group |
| usual intakeAlso: Usual groupbaseliner | Other | ordinary group |
Primary outcome
postoperative ammonia levels
Time frame: 3 points; preoperative baseline, postoperative day 1, and day3
change from preoperative baseline at postoperative day 1 and day3
1 secondary outcome
length of hospitalization after liver resection
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Derived from this study: PubMed 31599019Okabayashi T, Sui K, Mastumoto T, Iwata J, Morita S, Iiyama T, Shimada Y. l-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients. JPEN J Parenter Enteral Nutr. 2020 Jul;44(5):823-830. doi: 10.1002/jpen.1720. Epub 2019 Oct 9.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing L-carnitine and usual intake in people with Ammonia Metabolism, run by Kochi University at 1 site in Japan.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Jan 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 Japan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takehiro Okabayashi, MD (+81 88-837-3000, tokabaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative ammonia levels (time frame: 3 points; preoperative baseline, postoperative day 1, and day3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021876, which also lists 1 linked publication.
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 16 Jan 2017.