The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver
NCT ID: NCT03319199
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2017-10-30
2018-07-25
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
"SLIM WATER"
2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks
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".
Placebo - water
for a duration of 16 weeks
Interventions
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"SLIM WATER"
2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks
Placebo - water
for a duration of 16 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients with diagnosis of NAFLD when other etiologies for fatty liver were ruled out.
* Patients who sign a confirmed consent.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Rawi Hazzan
OTHER
Responsible Party
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Rawi Hazzan
Principal Investigator
Locations
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Haemek medical center
Afula, , Israel
Countries
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Other Identifiers
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0068-16-EMC
Identifier Type: -
Identifier Source: org_study_id
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