- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01956825
The Effect Of Dual Treatment With L-Carnitine And Magnesium On Fatty Liver
THE EFFECT OF DUAL TREATMENT WITH L-CARNITINE AND MAGNESIUM ON Patients With Non Alcoholic Fatty Liver Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to determine whether the dual therapy of the amino acid L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease.
the study is an interventional one in which 60 patients who by definition have non alcoholic fatty licer disease (NAFLD) are divided randomly (double blind) into 2 groups: group 1: "study group". receive a product (flavoured water) which contains L-CARNITINE an magnesium. group 2: control. receive placebo. regular water. Length of trial - 12 weeks. The patients will be followed on a weekly base and variuos parameters will be compared (weight, lipid profile, insulin resistance etc.).
"fibrotest" will be used at the beginning of the trial and at the end (week 12) comparing the fat content before and after the treatment.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: DAN FELDMAN, MD
- Phone Number: 0522794025
- Email: danifel100@gmail.com
Study Contact Backup
- Name: YONA KITAY, MD
- Phone Number: 09-7471560
- Email: yonaki@clalit.org.il
Study Locations
-
-
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Kfar Saba, Israel
- Meir Hospital
-
Contact:
- DAN FELDMAN, MD
- Phone Number: 0522794025
- Email: danifel100@gmail.com
-
Contact:
- YONA KITAY, MD
- Phone Number: 09-7471560
- Email: yonaki@clalit.org.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
age>18, <80 y evidence to non alcoholic fatty liver disease
Exclusion Criteria:
age<18, >80 y pregnancy renal failure congestive heart failure active malignancy liver disease - etiology other than non alcoholic fatty liver disease (NAFLD). hypothyroidism/cushing total prenteral nutrition (TPN) in the last 6 month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: water
just water
|
|
EXPERIMENTAL: L-CARNITINE AND MAGNESIUM ("slim water" product)
The experimental arm will receive a product "slim water", which contains 150 mg magnesium lactate and 2000 mg L-carnitine.
The purpose is to follow the patients and examine several metabolic parameters over time (liver function test, lipid profile, liver fat content, etc.) and by that to show and prove the positive effect of the experimental treatment over placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
effect of LCARNITINE and magnesium treatment on the liver fat content
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect of L-CARNITINE and magnesium treatment on the metabolic panel
Time Frame: 12 weeks
|
hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DAN FELDMAN, MD, Meir Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC13023-13CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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