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The Effect Of Dual Treatment With 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01956825
Recruitment Status : Unknown
Verified September 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date  ICMJE September 12, 2013
First Posted Date  ICMJE October 8, 2013
Last Update Posted Date October 8, 2013
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
effect of LCARNITINE and magnesium treatment on the liver fat content [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect Of Dual Treatment With L-Carnitine And Magnesium On Fatty Liver
Official Title  ICMJE THE EFFECT OF DUAL TREATMENT WITH L-CARNITINE AND MAGNESIUM ON Patients With Non Alcoholic Fatty Liver Disease
Brief 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non Alcoholic Fatty Liver Disease
Intervention  ICMJE Dietary Supplement: "slim water"
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: "slim water"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 7, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01956825
Other Study ID Numbers  ICMJE MMC13023-13CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: DAN FELDMAN, MD Meir Medical Center
PRS Account Meir Medical Center
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP