Clinical trial NCT03749070: Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial
Official title: Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Non-Alcoholic Fatty Liver Disease
sylimarin
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial, randomized, double-blind and controlled
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absence or change in NAFLD degree
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
Secondary outcomes:
measure: Lipid profile
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
measure: Fasting blood glucose
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
measure: Glycated haemoglobin
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
measure: Insulin
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
measure: Serum Iron
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
measure: Transferrin saturation
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
measure: Serum ferritin
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
measure: Hepatic transaminases
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
measure: gamma glutamyl transferase
timeFrame: They will be dosed at baseline and after 12 weeks of intervention.
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Camila Ribeiro de Avelar
state: Bahia
Study officials:
References: