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

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ClinicalTrials.gov Identifier: NCT03319199
Recruitment Status : Not yet recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
HaEmek Medical Center, Israel
Information provided by (Responsible Party):
RAWI HAZZAN, HaEmek Medical Center, Israel

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.


Condition or disease Intervention/treatment Phase
Fatty Liver, Nonalcoholic Dietary Supplement: "SLIM WATER" Other: Placebo - water Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: Primary treatment Arm
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"
2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks

Placebo Comparator: Placebo Arm
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
for a duration of 16 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319199


Contacts
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Contact: Rawi Hazzan, MD +972-46495169 ravih@clalit.org.il

Sponsors and Collaborators
RAWI HAZZAN
HaEmek Medical Center, Israel

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Responsible Party: RAWI HAZZAN, Principal Investigator, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03319199     History of Changes
Other Study ID Numbers: 0068-16-EMC
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases