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NCT01956825 Clinical Trial

The Effect Of Dual Treatment With L-Carnitine And Magnesium On Fatty Liver

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:
THE EFFECT OF DUAL TREATMENT WITH L-CARNITINE AND MAGNESIUM ON Patients With Non Alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01956825
Other study ID # MMC13023-13CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received September 12, 2013
Last updated October 7, 2013
Start date January 2014
Est. completion date April 2014

Study information
Verified date September 2013
Source Meir Medical Center
Contact DAN FELDMAN, MD
Phone 0522794025
Email danifel100@gmail.com
Is FDA regulated No
Health authority Israel: Clalit Health Services
Study type Interventional

Clinical Trial Summary

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 (NAFLD).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• "slim water"

Locations
Country Name City State
Israel Meir Hospital Kfar Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary effect of LCARNITINE and magnesium treatment on the liver fat content 12 weeks Yes
Secondary effect of L-CARNITINE and magnesium treatment on the metabolic panel hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance 12 weeks Yes
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