Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial
1 other identifier
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedStudy Start
First participant enrolled
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedAugust 2, 2022
August 1, 2022
3.5 years
October 28, 2018
August 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Lipid profile
They will be dosed at baseline and after 12 weeks of intervention.
Fasting blood glucose
They will be dosed at baseline and after 12 weeks of intervention.
Glycated haemoglobin
They will be dosed at baseline and after 12 weeks of intervention.
Insulin
They will be dosed at baseline and after 12 weeks of intervention.
Serum Iron
They will be dosed at baseline and after 12 weeks of intervention.
- +4 more secondary outcomes
Study Arms (2)
Silymarin
ACTIVE COMPARATORPatients 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.
Placebo
PLACEBO COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults between 20 and 60 years of age, both men and women,
- Clinical diagnosis of NAFLD, confirmed by imaging exams,
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Camila Ribeiro de Avelar
Salvador, Estado de Bahia, 40.110.060, Brazil
Related Publications (1)
de Avelar CR, Nunes BVC, da Silva Sassaki B, Dos Santos Vasconcelos M, de Oliveira LPM, Lyra AC, Bueno AA, de Jesus RP. Efficacy of silymarin in patients with non-alcoholic fatty liver disease - the Siliver trial: a study protocol for a randomized controlled clinical trial. Trials. 2023 Mar 10;24(1):177. doi: 10.1186/s13063-023-07210-6.
PMID: 36899430DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor student
Study Record Dates
First Submitted
October 28, 2018
First Posted
November 21, 2018
Study Start
February 15, 2019
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
August 2, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share