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

NCT03319199 | Completed DMC

• 1 other identifier: 0068-16-EMC
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (2)

• The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.

  Measured with blood test in IU/L

  24 weeks

• Decline in serum levels of Alanine transaminase (ALT) to normal value.

  Measured with blood test in IU/L

  24 weeks

Secondary Outcomes (2)

• Improvement in radiological hepatic steatosis .

  24 weeks

• Improvement in lipid profile.

  24 weeks

Study Arms (2)

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.

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".

Other: Placebo - water

Interventions

"SLIM WATER" DIETARY_SUPPLEMENT

2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks

Primary treatment Arm

Placebo - water OTHER

for a duration of 16 weeks

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rawi Hazzan: lead
• HaEmek Medical Center, Israel: collaborator

Study Sites (1)

Haemek medical center

Afula, 1834111, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 24, 2017
• Study Start: October 30, 2017
• Primary Completion: January 10, 2018
• Study Completion: July 25, 2018
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

IL (1)