Fatty Liver, NonalcoholicNCT03319199
The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver
A study testing "SLIM WATER" in people with Fatty Liver, Nonalcoholic, run by Rawi Hazzan at 1 site in Israel.
Trial summary
L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is involved in transporting fatty acids across the mitochondrial membrane, it could be an important component in treating a fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fatty Liver, Nonalcoholic
- What is being tested?
- "SLIM WATER"
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Oct 2017to 25 Jul 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female between the age 18 and 75.
- Patients with diagnosis of NAFLD when other etiologies for fatty liver were ruled out.
- Patients who sign a confirmed consent.
Who cannot join
- Patients with liver failure.
- Patients with acute or chronic renal failure ( CCT< 50 ml/min or creatinine > 1.5 mg/dl)
- Patients with congestive heart failure (NYHA 3-4)
- Patients with active cancer
- Patients on Estrogen therapy, MTX, chloroquine.
- Patients with a history of Hypothyroidism or Cushing disease.
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- Patients who received TPN in the past 6 months.
- Patients with chronic liver disease, A1AT, Hemochromatosis, Wilson, Autoimmune, Toxic injury.
- Patients on anticoagulation therapy - Coumadin.
- Patients who use valproic acid therapy.
- Children, Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver
L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is involved in transporting fatty acids across the mitochondrial membrane, it could be an important component in treating a fatty liver disease.
The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine and Magnesium as a treatment for fatty liver.
Read the detailed description
A phase 3, randomized, double blind placebo controlled study that evaluate the efficacy of L-Carnitine and Magnesium as a treatment for fatty liver, 60 eligible patients with a diagnosis of NAFDL will be randomly assigned in a 1:1 ratio to receive either the trial product " SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks, or placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER". 'Follow up time is estimated to be 24 week based on monthly clinic visits and accordingly assessment of lipid profile, weight and insulin resistance.
Fibrotest will be used at the beginning of the trial and at the end (week 16) comparing the fat content before and after the treatment.
- Conditions
- Fatty Liver, Nonalcoholic
- Being tested
- "SLIM WATER", Placebo - water
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"SLIM WATER"Dietary supplement
2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks
Placebo - waterOther
for a duration of 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Primary treatment Arm | Active comparator | patients with a diagnosis of NAFDL will be randomly receive trial product "SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks. Receives: Dietary Supplement: "SLIM WATER" |
| Placebo Arm | Placebo comparator | patients with a diagnosis of NAFDL will be randomly receive placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER". Receives: Other: Placebo - water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.
Measured with blood test in IU/L
Measured: 24 weeks
Decline in serum levels of Alanine transaminase (ALT) to normal value.
Measured with blood test in IU/L
Measured: 24 weeks
Secondary outcomes (2)
Improvement in radiological hepatic steatosis .
Liver steatosis measured by Transient Elastography - FibrsoScan done at recruitment day and at the end of treatment.
Measured: 24 weeks
Improvement in lipid profile.
Measured with blood test.
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 posted24 Oct 2017
- Study start30 Oct 2017
- Primary completion10 Jan 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawi Hazzan
- Sponsor type
- University, hospital or other
- Collaborators
- HaEmek Medical Center, Israel
- Responsible party
- Sponsor-investigator, Rawi Hazzan, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319199
- Sponsor's protocol ID
- 0068-16-EMC
- Status last verified
- Aug 2019
- First submitted
- 10 Oct 2017
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver
- ClinicalTrials.gov ID
- NCT03319199
- Acronym / sponsor ID
- 0068-16-EMC
- Conditions
- Fatty Liver, Nonalcoholic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rawi HazzanUniversity, hospital or other
- Collaborators
- HaEmek Medical Center, Israel
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 24 Oct 2017 (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.
L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is involved in transporting fatty acids across the mitochondrial membrane, it could be an important component in treating a fatty liver disease.
The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine and Magnesium as a treatment for fatty liver.
Detailed description
A phase 3, randomized, double blind placebo controlled study that evaluate the efficacy of L-Carnitine and Magnesium as a treatment for fatty liver, 60 eligible patients with a diagnosis of NAFDL will be randomly assigned in a 1:1 ratio to receive either the trial product " SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks, or placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER". 'Follow up time is estimated to be 24 week based on monthly clinic visits and accordingly assessment of lipid profile, weight and insulin resistance.
Fibrotest will be used at the beginning of the trial and at the end (week 16) comparing the fat content before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary treatment Arm | Active comparator | Dietary Supplement: "SLIM WATER"patients with a diagnosis of NAFDL will be randomly receive trial product "SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks. |
| Placebo Arm | Placebo comparator | Other: Placebo - waterpatients with a diagnosis of NAFDL will be randomly receive placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER". |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and Female between the age 18 and 75.
- Patients with diagnosis of NAFLD when other etiologies for fatty liver were ruled out.
- Patients who sign a confirmed consent.
Key exclusion criteria (11 listed)
- Patients with liver failure.
- Patients with acute or chronic renal failure ( CCT< 50 ml/min or creatinine > 1.5 mg/dl)
- Patients with congestive heart failure (NYHA 3-4)
- Patients with active cancer
- Patients on Estrogen therapy, MTX, chloroquine.
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 |
|---|---|---|
| "SLIM WATER"2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks | Dietary supplement | Primary treatment Arm |
| Placebo - waterfor a duration of 16 weeks | Other | Placebo Arm |
Primary outcome
The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.
Time frame: 24 weeks
Measured with blood test in IU/L
Decline in serum levels of Alanine transaminase (ALT) to normal value.
Time frame: 24 weeks
Measured with blood test in IU/L
2 secondary outcomes
Improvement in radiological hepatic steatosis .
Time frame: 24 weeks
Improvement in lipid profile.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "SLIM WATER" in people with Fatty Liver, Nonalcoholic, run by Rawi Hazzan at 1 site in Israel.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 9 Aug 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value. (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 9 Aug 2019.