Clinical trial NCT03319199: The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver, Nonalcoholic
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: HaEmek Medical Center, Israel
First posted: 2017-10-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.
timeFrame: 24 weeks
measure: Decline in serum levels of Alanine transaminase (ALT) to normal value.
timeFrame: 24 weeks
Secondary outcomes:
measure: Improvement in radiological hepatic steatosis .
timeFrame: 24 weeks
measure: Improvement in lipid profile.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center
Study officials:
References: