Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis

Tracking Information
First Submitted Date ICMJE	July 11, 2012
First Posted Date ICMJE	July 26, 2012
Last Update Posted Date	August 20, 2014
Study Start Date ICMJE	November 2011
Actual Primary Completion Date	March 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 23, 2012)	Impact on biochemical and echosonographic parameters [ Time Frame: 6 months ]; Identify and measure if patients with metabolic syndrome with NALFD under Siliphos (140mg) + Selenium (15mcg) - Methionine (3mg) + Alfa lipoic acid (200mg) treatment added to conventional therapy improves echosonographic pattern measure accord bright scale and biochemical parameters like LFT´s compared with conventional therapy alone (metformin + diet + exercise).
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01650181 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 23, 2012)	Identify changes in anthropometric parameters [ Time Frame: 6 months ]; Identify and measure changes in anthropometrics parameters of metabolic syndrome like BMI, fasting glucose, lipid profile, arterial pressure, abdominal perimeter, waist index.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
Official Title ICMJE	Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis
Brief Summary	Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the upcoming years, the economic burden of this disease will increase and will mean an important problem for our health system due to obesity epidemic. There are several treatments for non-alcoholic steatohepatitis; however, none of them have overcome a healthy lifestyle including diet, exercise and some drugs related with insulin metabolism. There after, using hepatoprotective drugs and antioxidants have been recommended as an eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis. Being this approach not only an experimental item yet but also an unavoidable reality. The purpose of this randomized controlled study is explore the effects of siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic parameters.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Supportive Care
Condition ICMJE	Liver Disease
Intervention ICMJE	Drug: Metformin Patients with Steatohepatitis treated with diet, exercise and metformin; Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid Patients with Steatohepatitis treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID; Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid Patients with fatty liver treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID; Drug: Metformin Patients with fatty liver treated with diet, exercise and metformin
Study Arms	Active Comparator: Metformin Patients treated with diet, exercise and metformin Interventions: Drug: Metformin Drug: Metformin; Active Comparator: Suplement Patients treated with diet, exercise and metformin plus Siliphos (140mg) + Selenium (15mcg) -Methionine 3mg + Alpha Lipoic Acid (200mg). Interventions: Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
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	Completed
Actual Enrollment ICMJE; (submitted: August 18, 2014)	50
Original Estimated Enrollment ICMJE; (submitted: July 23, 2012)	40
Actual Study Completion Date	June 2014
Actual Primary Completion Date	March 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients with Metabolic Syndrome according to ATP III Criteria; Non smokers; Without intake of vitamins or herbal medicine for at least one month; Without uncontrolled glycemic levels; Compatible ultrasound and/or histological report Exclusion Criteria: Alcohol ingest > 50 gr weekly or chronic alcoholism; Creatine serum > 2 mg/dL; Potassium serum > 5.5 mEq/L; Allergic to metformin or any components of the study; Pregnancy; Anomalies of blood coagulation or liver anatomic; Patients with diseases and/or treatment that cause fatty liver or steatohepatitis; Body weight change > 10% in the last 5 weeks
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Mexico
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01650181
Other Study ID Numbers ICMJE	GAS-399-11/11/1
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Sponsor ICMJE	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Aldo Torre Delgadillo, M.D., M. Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
PRS Account	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Verification Date	August 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP