The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver

Fatty Liver, Nonalcoholic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319199
• Other study ID #: 0068-16-EMC
• Status: Completed
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: July 25, 2018

Study information

• Verified date: August 2019
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine and Magnesium as a treatment for fatty liver.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 25, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• "SLIM WATER"
2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks

Other:
• Placebo - water
for a duration of 16 weeks

Locations

Country	Name	City	State
Israel	Haemek medical center	Afula

Sponsors (2)

Lead Sponsor	Collaborator
Rawi Hazzan	HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.	Measured with blood test in IU/L	24 weeks
Primary	Decline in serum levels of Alanine transaminase (ALT) to normal value.	Measured with blood test in IU/L	24 weeks
Secondary	Improvement in radiological hepatic steatosis .	Liver steatosis measured by Transient Elastography - FibrsoScan done at recruitment day and at the end of treatment.	24 weeks
Secondary	Improvement in lipid profile.	Measured with blood test.	24 weeks