Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03749070
• Other study ID #: 2.635.954
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2022
• Source: Hospital Universitário Professor Edgard Santos
• Contact: Camila Avelar
• Phone: +55 (71)991540434
• Email: contato[@]camilaavelar.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent chronic liver diseases in Brazil and its treatment is still limited. Thus, this project aims to conduct a double-blind, controlled, randomized clinical trial to evaluate the effect of silymarin on laboratory markers and clinical evolution of adult patients with NAFLD treated at Edgard Santos Hospital, as well as identify the dietary pattern of these individuals.

Description:

Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent chronic liver diseases in Brazil. It has a significantly increasing incidence today and is considered an important global health problem. It affects approximately 20 to 30% of the adult population and increases according to the severity of the risk factors. The diagnosis of this disease usually occurs in 10 to 20% of the non-obese individuals, 50% in the overweight and 80 to 90% in the obese, being twice as present in individuals with Metabolic Syndrome. Pharmacological treatment options for NAFLD are still limited and Silybum marianum, one of the most sought-after herbal remedies in patients with liver disease, is commonly used by patients because of the claim of the hepatoprotective effect of silymarin. Studies have demonstrated the therapeutic potential of silymarin in patients with NAFLD, but clinical trials with more judicious methodological designs is still needed to prove these effects. Thus, this project aims to evaluate the efficacy of silymarin in adult patients with NAFLD seen at the Clinic of Nutrition and Hepatology of Edgard Santos Hospital. A randomized, double-blind, controlled clinical trial lasting 12 weeks will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adults between 20 and 60 years of age, both men and women,
• Clinical diagnosis of NAFLD, confirmed by imaging exams,

Exclusion Criteria:

• Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation.
• Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification)
• Patients with schistosomiasis;
• Hemochromatosis
• Wilson's disease
• Viral or autoimmune hepatitis
• HIV virus carriers
• Woman who is breastfeeding
• Users of illicit drugs
• Patients with an intake of more than 20 g / day of alcohol and / or past alcoholism with abstention less than 6 months;
• Patients with ingestion of medications such as steroids, estrogens, amiodarone, warfarin, anti-convulsants, antipsychotics, tamoxifen or other chemotherapeutic agents in the last 6 months
• Patients with clinically manifest infections or inflammation, surgery, trauma or hospitalization in the last 30 days
• Chronic non-hepatic degenerative diseases (sclerosis, Parkinson's disease or Alzheimer's disease)
• Patients who do not participate in all stages of the research.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Silymarin
It is a randomized, double-blind, controlled clinical trial to be performed at outpatient level. The intervention will last 12 weeks and the invited participants will be patients attended at the outpatient clinic of the Edgard Santos Hospital, which will be randomized into two groups: control and intervention. Data on laboratory and clinical markers, imaging, nutritional and dietary assessment will be collected at the beginning and end of the trial for comparison purposes.

Locations

Country	Name	City	State
Brazil	Camila Ribeiro de Avelar	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Camila Ribeiro de Avelar

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence or change in NAFLD degree	Absence or change in NAFLD degree, assessed by the value of the difference in the attenuation coefficient between liver and spleen obtained by computed tomography of the upper abdomen performed at the beginning and at the end of the study.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	Lipid profile	Total cholesterol (mg/dL), LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL), VLDL-cholesterol (mg/dL) and triglycerides (mg/dL) will be measured before and after the intervention.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	Fasting blood glucose	Fasting blood glucose (mg/dL) will be measured before and after the intervention.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	Glycated haemoglobin	Hb A1c (%) will be measured before and after the intervention.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	Insulin	Insulin (µU/mL) will be measured before and after the intervention.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	Serum Iron	Serum iron (mcg/dL) will be measured before and after intervention.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	Transferrin saturation	Transferrin saturation (%) will be measured before and after intervention.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	Serum ferritin	Serum ferritin will be evaluated in µg/L before and after intervention.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	Hepatic transaminases	Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L before and after intervention.	They will be dosed at baseline and after 12 weeks of intervention.
Secondary	gamma glutamyl transferase	Gamma glutamyl transferase will be evaluated in U/L before and after intervention.	They will be dosed at baseline and after 12 weeks of intervention.