NCT01956825

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 8, 2013

Status Verified

September 1, 2013

Enrollment Period

3 months

First QC Date

September 12, 2013

Last Update Submit

October 7, 2013

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

non alcoholic fatty liver diseaseLCARNITINE amino acidmagnesiumfat content

Outcome Measures

Primary Outcomes (1)

  • effect of LCARNITINE and magnesium treatment on the liver fat content

    12 weeks

Secondary Outcomes (1)

  • effect of L-CARNITINE and magnesium treatment on the metabolic panel

    12 weeks

Study Arms (2)

water

PLACEBO COMPARATOR

just water

L-CARNITINE AND MAGNESIUM ("slim water" product)

EXPERIMENTAL

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"

Interventions

"slim water"DIETARY_SUPPLEMENT
L-CARNITINE AND MAGNESIUM ("slim water" product)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\>18, \<80 y evidence to non alcoholic fatty liver disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Hospital

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • DAN FELDMAN, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DAN FELDMAN, MD

CONTACT

0522794025danifel100@gmail.com

YONA KITAY, MD

CONTACT

09-7471560yonaki@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

October 8, 2013

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

October 8, 2013

Record last verified: 2013-09

Locations

IL(1)