Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01956825
First received: September 12, 2013
Last updated: October 7, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention Phase
Non Alcoholic Fatty Liver Disease
Dietary Supplement: "slim water"
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: THE EFFECT OF DUAL TREATMENT WITH L-CARNITINE AND MAGNESIUM ON Patients With Non Alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • effect of LCARNITINE and magnesium treatment on the liver fat content [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • effect of L-CARNITINE and magnesium treatment on the metabolic panel [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: "slim water"

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956825

Contacts
Contact: DAN FELDMAN, MD 0522794025 danifel100@gmail.com
Contact: YONA KITAY, MD 09-7471560 yonaki@clalit.org.il

Locations
Israel
Meir Hospital Recruiting
Kfar Saba, Israel
Contact: DAN FELDMAN, MD    0522794025    danifel100@gmail.com   
Contact: YONA KITAY, MD    09-7471560    yonaki@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: DAN FELDMAN, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01956825     History of Changes
Other Study ID Numbers: MMC13023-13CTIL
Study First Received: September 12, 2013
Last Updated: October 7, 2013
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
non alcoholic fatty liver disease
LCARNITINE amino acid
magnesium
fat content

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Carnitine
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014