Alcoholic Liver DiseasesNCT03938662
S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
A study testing formulation containing S-Adenosyl methionine and choline in people with Alcoholic Liver Diseases, run by University Clinic Dr Dragisa Misovic-Dedinje at 1 site in Serbia.
Trial summary
The study will assess the effect of treatment with formulation containing S-Adenosyl methionine and choline, on patients with alcoholic liver disease. Half of the patients included will receive named formulation once daily for 24 weeks while other half will receive placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Liver Diseases
- What is being tested?
- formulation containing S-Adenosyl methionine and choline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSerbia
- Study dates
- 9 May 2019to 1 Apr 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- alcoholic liver disease
Who cannot join
- hepatitis B
- hepatitis C
- autoimmune hepatitis
- hemochromatosis
- Wilson's disease
- hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
University Clinic Dr Dragisa Misovic-Dedinje
Belgrade, 11000
Nikola Panic, PhD, +381643509133, nikola.panicmail@gmail.com
About this study
Official title: Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
The study will assess the effect of treatment with formulation containing S-Adenosyl methionine and choline, on patients with alcoholic liver disease.
Half of the patients included will receive named formulation once daily for 24 weeks while other half will receive placebo.
Read the detailed description
Choline and S-Adenosyl methionine are nutrients both showing hepatoprotective effects.
Choline helps liver metabolise glucose and lipids and repair cell membrane. S-Adenosyl methionine is essential for the synthesis of glutathione, a main cellular antioxidant showing its protective effect against free radicals, among others in liver tissue. Furthermore S-Adenosyl methionine is involved in regulation of hepatocyte growth, differentiation, and death. It also enables endogenous production of small amount of choline. Although human organism has capacity for production of small amount of S-Adenosyl methionine, damaged liver can not produce it or produce it insufficient amounts.
Having this in mind it can be hypothesised that administration of choline and S-Adenosyl methionine can be beneficial in patients with alcoholic liver disease.
- Conditions
- Alcoholic Liver Diseases
- Being tested
- formulation containing S-Adenosyl methionine and choline, Placebo
- Keywords
- alcoholic liver diseases, S-Adenosyl methionine, choline
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formulation containing S-Adenosyl methionine and cholineDietary supplement
Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.
PlaceboDietary supplement
Placebo of same appearance, colour and taste,
| Study group | Role | What they receive |
|---|---|---|
| S-Adenosyl methionine and choline | Experimental | Patients in will be administered with formulation of 100 mg of S-Adenosyl methionine and 82.5 mg of choline, once daily for 24 weeks. Receives: Dietary Supplement: formulation containing S-Adenosyl methionine and choline |
| Placebo | Placebo comparator | Patients in will be administered with placebo once daily for 24 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine aminotransferase (ALT)
Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
Measured: 24 weeks
Secondary outcomes (4)
Aspartate aminotransferase (AST)
Aspartate aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
Measured: 24 weeks
Gamma-glutamyl transferase (GGT)
Gamma-glutamyl transferase will be measured at the enrolment and after 24 weeks of treatment.
Measured: 24 weeks
Alkaline phosphatase (ALP)
Alkaline phosphatase will be measured at the enrolment and after 24 weeks of treatment.
Measured: 24 weeks
Serum bilirubin
Bilirubin levels will be measured at the enrolment and after 24 weeks of treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start9 May 2019
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinic Dr Dragisa Misovic-Dedinje
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikola Panic, University Clinic Dr Dragisa Misovic-Dedinje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938662
- Sponsor's protocol ID
- UCDragisaMisovic
- Status last verified
- May 2019
- First submitted
- 30 Apr 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
- ClinicalTrials.gov ID
- NCT03938662
- Acronym / sponsor ID
- UCDragisaMisovic
- Conditions
- Alcoholic Liver Diseases
- Keywords
- alcoholic liver diseases, S-Adenosyl methionine, choline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Clinic Dr Dragisa Misovic-DedinjeUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 6 May 2019 (actual)
- 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.
The study will assess the effect of treatment with formulation containing S-Adenosyl methionine and choline, on patients with alcoholic liver disease.
Half of the patients included will receive named formulation once daily for 24 weeks while other half will receive placebo.
Detailed description
Choline and S-Adenosyl methionine are nutrients both showing hepatoprotective effects.
Choline helps liver metabolise glucose and lipids and repair cell membrane. S-Adenosyl methionine is essential for the synthesis of glutathione, a main cellular antioxidant showing its protective effect against free radicals, among others in liver tissue. Furthermore S-Adenosyl methionine is involved in regulation of hepatocyte growth, differentiation, and death. It also enables endogenous production of small amount of choline. Although human organism has capacity for production of small amount of S-Adenosyl methionine, damaged liver can not produce it or produce it insufficient amounts.
Having this in mind it can be hypothesised that administration of choline and S-Adenosyl methionine can be beneficial in patients with alcoholic liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-Adenosyl methionine and choline | Experimental | Dietary Supplement: formulation containing S-Adenosyl methionine and cholinePatients in will be administered with formulation of 100 mg of S-Adenosyl methionine and 82.5 mg of choline, once daily for 24 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients in will be administered with placebo once daily for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- alcoholic liver disease
Key exclusion criteria (6 listed)
- hepatitis B
- hepatitis C
- autoimmune hepatitis
- hemochromatosis
- Wilson's 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 |
|---|---|---|
| formulation containing S-Adenosyl methionine and cholinePatients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks. | Dietary supplement | S-Adenosyl methionine and choline |
| PlaceboPlacebo of same appearance, colour and taste, | Dietary supplement | Placebo |
Primary outcome
Alanine aminotransferase (ALT)
Time frame: 24 weeks
Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
4 secondary outcomes
Aspartate aminotransferase (AST)
Time frame: 24 weeks
Gamma-glutamyl transferase (GGT)
Time frame: 24 weeks
Alkaline phosphatase (ALP)
Time frame: 24 weeks
Serum bilirubin
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- 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 study testing formulation containing S-Adenosyl methionine and choline in people with Alcoholic Liver Diseases, run by University Clinic Dr Dragisa Misovic-Dedinje at 1 site in Serbia.
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 6 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 29 May 2019. 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 Serbia. 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.
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 Nikola Panic, PhD (+381 11 3630600, nikola.panicmail@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alanine aminotransferase (ALT) (time frame: 24 weeks). 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 29 May 2019.