Back to resultsEfficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Silymarin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Non-Alcoholic Fatty Liver Disease, sylimarin
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.
Sites / Locations
- Camila Ribeiro de AvelarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Silymarin
Placebo
Arm Description
Patients will receive 2 capsules containing a total of 700mg of silymarin, 8mg of vitamin E and 50mg of phosphatidylcholine, in addition to the excipient, which should be ingested daily for 12 weeks.
Patients will also receive similarly 2 capsules per day, but without the bioactive principle tested (silymarin). Therefore, the capsules in the control group will contain only 700 mg of maltodextrin, a neutral food component derived from starch, in addition to the excipient and the same amount of vitamin E and phosphatidylcholine to balance the two groups.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Fasting blood glucose
Fasting blood glucose (mg/dL) will be measured before and after the intervention.
Glycated haemoglobin
Hb A1c (%) will be measured before and after the intervention.
Insulin
Insulin (µU/mL) will be measured before and after the intervention.
Serum Iron
Serum iron (mcg/dL) will be measured before and after intervention.
Transferrin saturation
Transferrin saturation (%) will be measured before and after intervention.
Serum ferritin
Serum ferritin will be evaluated in µg/L before and after intervention.
Hepatic transaminases
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L before and after intervention.
gamma glutamyl transferase
Gamma glutamyl transferase will be evaluated in U/L before and after intervention.
Full Information
NCT ID
NCT03749070
First Posted
October 28, 2018
Last Updated
August 1, 2022
Sponsor
Camila Ribeiro de Avelar
1. Study Identification
Unique Protocol Identification Number
NCT03749070
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Camila Ribeiro de Avelar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
Non-Alcoholic Fatty Liver Disease, sylimarin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial, randomized, double-blind and controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Silymarin
Arm Type
Active Comparator
Arm Description
Patients will receive 2 capsules containing a total of 700mg of silymarin, 8mg of vitamin E and 50mg of phosphatidylcholine, in addition to the excipient, which should be ingested daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will also receive similarly 2 capsules per day, but without the bioactive principle tested (silymarin). Therefore, the capsules in the control group will contain only 700 mg of maltodextrin, a neutral food component derived from starch, in addition to the excipient and the same amount of vitamin E and phosphatidylcholine to balance the two groups.
Intervention Type
Dietary Supplement
Intervention Name(s)
Silymarin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Absence or change in NAFLD degree
Description
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.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Secondary Outcome Measure Information:
Title
Lipid profile
Description
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.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Title
Fasting blood glucose
Description
Fasting blood glucose (mg/dL) will be measured before and after the intervention.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Title
Glycated haemoglobin
Description
Hb A1c (%) will be measured before and after the intervention.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Title
Insulin
Description
Insulin (µU/mL) will be measured before and after the intervention.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Title
Serum Iron
Description
Serum iron (mcg/dL) will be measured before and after intervention.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Title
Transferrin saturation
Description
Transferrin saturation (%) will be measured before and after intervention.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Title
Serum ferritin
Description
Serum ferritin will be evaluated in µg/L before and after intervention.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Title
Hepatic transaminases
Description
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L before and after intervention.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
Title
gamma glutamyl transferase
Description
Gamma glutamyl transferase will be evaluated in U/L before and after intervention.
Time Frame
They will be dosed at baseline and after 12 weeks of intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camila Avelar
Phone
+55 (71)991540434
Ext
+55
Email
contato@camilaavelar.com.br
Facility Information:
Facility Name
Camila Ribeiro de Avelar
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40.110.060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila Avelar
Phone
+55(71)991540434
Email
contato@camilaavelar.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial
We'll reach out to this number within 24 hrs