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Completed

NCT Number: NCT03319199

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.

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Key information

Conditions

Fatty Liver, Nonalcoholic Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haemek medical center

Afula, 1834111, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"SLIM WATER"

Dietary Supplement

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

Placebo - water

Other

for a duration of 16 weeks

Primary outcomes

  1. 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

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

    Time frame: 24 weeks

    Measured with blood test in IU/L

Secondary outcomes

  1. Improvement in radiological hepatic steatosis .

    Time frame: 24 weeks

    Liver steatosis measured by Transient Elastography - FibrsoScan done at recruitment day and at the end of treatment.

  2. Improvement in lipid profile.

    Time frame: 24 weeks

    Measured with blood test.

Sponsors and collaborators

Lead sponsor

Rawi Hazzan

Other

Collaborators

  • HaEmek Medical Center, Israel

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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