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

Primary Purpose

Fatty Liver, Nonalcoholic

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

"SLIM WATER"

Placebo - water

About this trial

This is an interventional treatment trial for Fatty Liver, Nonalcoholic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Haemek medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Primary treatment Arm

Placebo Arm

Arm Description

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.

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".

Outcomes

Primary Outcome Measures

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

Measured with blood test in IU/L

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

Measured with blood test in IU/L

Secondary Outcome Measures

Improvement in radiological hepatic steatosis .

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

Improvement in lipid profile.

Measured with blood test.

Full Information

NCT ID

NCT03319199

First Posted

October 10, 2017

Last Updated

August 8, 2019

Sponsor

Rawi Hazzan

Collaborators

HaEmek Medical Center, Israel

1. Study Identification

Unique Protocol Identification Number

NCT03319199

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

October 30, 2017 (Actual)

Primary Completion Date

January 10, 2018 (Actual)

Study Completion Date

July 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rawi Hazzan

Collaborators

HaEmek Medical Center, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver, Nonalcoholic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primary treatment Arm

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

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".

Intervention Type

Dietary Supplement

Intervention Name(s)

"SLIM WATER"

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo - water

Intervention Description

for a duration of 16 weeks

Primary Outcome Measure Information:

Title

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

Description

Measured with blood test in IU/L

Time Frame

24 weeks

Title

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

Description

Measured with blood test in IU/L

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Improvement in radiological hepatic steatosis .

Description

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

Time Frame

24 weeks

Title

Improvement in lipid profile.

Description

Measured with blood test.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Haemek medical center

City

Afula

ZIP/Postal Code

1834111

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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