The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03319199|
Recruitment Status : Not yet recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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
- Decline in serum levels of Alanine transaminase (ALT) to normal value. [ Time Frame: 24 weeks ]Measured with blood test in IU/L
- 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.
- Improvement in lipid profile. [ Time Frame: 24 weeks ]Measured with blood test.
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
|Contact: Rawi Hazzan, MDemail@example.com|