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Effect of Silymarin in Patients With Non-alcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749070
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Camila Ribeiro de Avelar, Hospital Universitário Professor Edgard Santos

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Dietary Supplement: Silymarin Not Applicable

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 effect of silymarin on laboratory markers and clinical evolution of adult patients with DHGNA seen at the Clinic of Nutrition and Hepatology of Edgard Santos Hospital, as well as to identify the dietary pattern of these individuals. It is also intended to develop and validate a Food Frequency Questionnaire (FFQ) for this patient population. A randomized, double-blind, controlled clinical trial lasting 12 weeks will be performed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical trial, randomized, double-blind and controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Effect of Silymarin on Clinical Evolution and Nutritional Variables of Patients With Non-alcoholic Fatty Liver Disease: Randomized Clinical Trial
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 4, 2021
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Active Comparator: Silymarin
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.
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, and physical activity level will be collected at the beginning and end of the trial for comparison purposes.

Placebo Comparator: Placebo
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.
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, and physical activity level will be collected at the beginning and end of the trial for comparison purposes.




Primary Outcome Measures :
  1. Hepatic transaminases [ Time Frame: They will be dosed at baseline and after 12 weeks of intervention. ]
    Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L before and after intervention.

  2. Serum ferritin [ Time Frame: They will be dosed at baseline and after 12 weeks of intervention. ]
    Serum ferritin will be evaluated in µg/L before and after intervention.


Secondary Outcome Measures :
  1. Lipid profile [ Time Frame: They will be dosed at baseline and after 12 weeks of intervention. ]
    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.

  2. Fasting blood glucose [ Time Frame: They will be dosed at baseline and after 12 weeks of intervention. ]
    Fasting blood glucose (mg/dL) will be measured before and after the intervention.

  3. Glycated haemoglobin [ Time Frame: They will be dosed at baseline and after 12 weeks of intervention. ]
    Hb A1c (%) will be measured before and after the intervention.

  4. Insulin [ Time Frame: They will be dosed at baseline and after 12 weeks of intervention. ]
    Insulin (µU/mL) will be measured before and after the intervention.

  5. Serum Iron [ Time Frame: They will be dosed at baseline and after 12 weeks of intervention. ]
    Serum iron (mcg/dL) will be measured before and after intervention.

  6. Transferrin saturation [ Time Frame: They will be dosed at baseline and after 12 weeks of intervention. ]
    Transferrin saturation (%) will be measured before and after intervention.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults between 20 and 60 years of age, both men and women,
  • Clinical diagnosis of NAFLD, confirmed by imaging exams,
  • Patients who present levels above the reference values of ALT, AST and ferritin.
  • Those who spontaneously agree to participate in the research, by signing the Term of Free and Informed Consent.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749070


Contacts
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Contact: Camila Avelar +55 (71)991540434 ext +55 contato@camilaavelar.com.br

Locations
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Brazil
Camila Ribeiro de Avelar Recruiting
Salvador, Bahia, Brazil, 40.110.060
Contact: Camila Avelar    +55(71)991540434    contato@camilaavelar.com.br   
Sponsors and Collaborators
Camila Ribeiro de Avelar
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Responsible Party: Camila Ribeiro de Avelar, Doctor student, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier: NCT03749070    
Other Study ID Numbers: 2.635.954
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camila Ribeiro de Avelar, Hospital Universitário Professor Edgard Santos:
Non-Alcoholic Fatty Liver Disease
sylimarin
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs