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SAMe Trial for Patients With Alcoholic Cirrhosis

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: NCT04250259
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Suthat Liangpunsakul, Indiana University

Brief Summary:
The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.

Condition or disease Intervention/treatment Phase
Alcoholic Cirrhosis Dietary Supplement: Placebo Dietary Supplement: SAMe 400 mg tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Multi-center, Randomized, Placebo-controlled Trial of S-Adenosylmethionine (SAMe) in Patients With Alcoholic Cirrhosis
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Alcoholic Cirrhosis on placebo
Dietary Supplement: Placebo
2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months

Experimental: 1,200 mg SAMe
SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months
Dietary Supplement: SAMe 400 mg tablet
SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months

No Intervention: Non-drinking Controls
Non-drinking healthy controls



Primary Outcome Measures :
  1. Measure the mortality of patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo [ Time Frame: Baseline to 24 months ]
    The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for patients with alcoholic cirrhosis

  1. Patients must have had alcohol consumption averaging at least 80 grams per day (for men) or 50 grams per day (for women), for at least 10 years. These criteria are based on epidemiological evidence of the alcohol-cirrhosis relationship. The cutoff was set at a relatively high level so as to minimize the chance that cirrhosis was caused by factors other than alcohol
  2. Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and
  3. subjects with clinical presentation either in Child Class A or B at the time of enrollment

Inclusion criteria for healthy control :

  1. individuals 18 to 70 years old
  2. able to provide informed consent
  3. subjects do not consume any alcohol or those who drink < 50 grams per day on average in women and < 80 grams per day on average in men and do not consume any alcohol within 3 months before the study and
  4. subjects are healthy without underlying acute or chronic medical conditions.

Exclusion criteria for patients with alcoholic cirrhosis

  1. Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
  2. Serum creatinine >1.5 mg/dl
  3. Known co-existing infection with hepatitis C, hepatitis B, or HIV
  4. Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study
  5. Gastrointestinal bleeding within the prior 28 days3
  6. Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
  7. Women who are pregnant, may become pregnant, or nursing
  8. Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery
  9. Subjects with history of/diagnosis of hepatocellular carcinoma
  10. Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study
  11. Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
  12. Systemic antibiotic use or use of rifaximin for 10 days or more in last 2 months before the enrollment.

Exclusion criteria for all healthy control participants:

  1. individuals under the age of 18 or over the age of 70
  2. not able to provide informed consent
  3. subjects who consume any alcohol or those who drink > 50 grams per day on average in women and > 80 grams per day on average in men and consume any alcohol within 3 months before the study and
  4. subjects that are unhealthy with underlying acute or chronic medical conditions.

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): NCT04250259


Contacts
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Contact: Kristina Chandler, BS (317) 988-4733 krimhick@iu.edu
Contact: AdePeju Oshodi, BS (317) 988-4545 afoshodi@iu.edu

Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Suthat Liangpunsakul, MD Indiana University
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Responsible Party: Suthat Liangpunsakul, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT04250259    
Other Study ID Numbers: SAMe Trial
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: January 2020

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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 Suthat Liangpunsakul, Indiana University:
Child Class A or B
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Alcoholic
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders