Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)

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. Read our disclaimer for details. Identifier: NCT01511523
Recruitment Status : Unknown
Verified January 2012 by Biovil Research Group, LLC.
Recruitment status was:  Enrolling by invitation
First Posted : January 18, 2012
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Biovil Research Group, LLC

Brief Summary:
A research study of a compound containing vitamin E, silymarin and carnitine, three over the counter supplements. The investigators hope to learn if the new supplement can safely and successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).

Condition or disease Intervention/treatment Phase
Non Alcoholic Fatty Liver Disease Dietary Supplement: RGMA001 Dietary Supplement: Sugar Pill Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD).
Study Start Date : January 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Arm Intervention/treatment
Active Comparator: RGMA001
Proprietary blend of Vitamin E, Silymarin, and Carnitine.
Dietary Supplement: RGMA001
3 capsules administered BID once a day.

Placebo Comparator: Sugar Pill
No treatment.
Dietary Supplement: Sugar Pill

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 30 weeks ]
    Normalization of hepatic AST, ALT, y-GT, albumin, alkaline phosphatase and total bilirubin.

Secondary Outcome Measures :
  1. Safety [ Time Frame: 30 weeks ]
    Vital signs, BMI, symptom directed physical exam, pregnancy tests, laboratory tests (hematology, and chemistry), clinical adverse events, dose modifications and treatment discontinuations related to adverse events or laboratory abnormalities.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female patients age 18 years and older.
  2. A clinical or histologic or radiographic diagnosis of NAFLD.
  3. Abnormities above normal range in hepatic function testing consisting of panels containing ALT, AST, AP, Total bilirubin and albumin.
  4. Negative urine pregnancy test (for females of childbearing potential) collected at screening followed by another negative serum pregnancy test collected within 24 hours prior to the first dose of study drug.
  5. Female patients of childbearing potential must be on adequate birth control.
  6. Willingness to give written informed consent and willingness to participate in and comply with the study requirements.

Exclusion Criteria:

  1. History of having received any investigational drug ≤ 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes.
  2. Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
  3. History or other evidence of a medical condition associated with chronic liver disease other than NAFLD (e.g., hemochromatosis, viral or autoimmune hepatitis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease, and/or toxin exposure).
  4. Females who are pregnant or breast feeding.
  5. Platelet count < 90 x 103 / µL (< 90 x 109 /L) at screening.
  6. Hemoglobin (Hgb) concentration < 12 g/dL (< 120 g/L) in females or < 13 g/dL (< 30 g/L) in males at screening.
  7. Any patient with a baseline increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic.
  8. Patients with history of severe psychiatric disease, including psychosis and/or severe depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease must have a psychiatric evaluation at screening to ensure the patient is now stable and the patient must agree to have continued monitoring by a mental health specialist at least every 4 weeks during the study.
  9. History of immunologically mediated disease [(e.g., vasculitis, cryoglobulinemia, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis (defined as affecting > 10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management, etc.
  10. Patients with evidence of decompensated liver disease including but not limited to ascites, esophageal varices, and hepatic encephalopathy.
  11. History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  12. History or other evidence of decompensated liver disease or Child-Pugh Grade B or higher [Appendix 1], coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease.
  13. One or more of the following conditions: (1) poorly controlled hypertension, OR (2) screening or baseline blood pressure ≥ 160 mmHg for systolic OR (3) screening or baseline blood pressure ≥ 100 mmHg for diastolic blood pressure.
  14. History of bleeding disorders or anticoagulant use
  15. Type I or II diabetes with HbA1C > 8.5% at screening.
  16. History or other evidence of chronic pulmonary disease associated with functional limitation.
  17. History of severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular disease). Patients with stable coronary artery disease (e.g., 6 months after by-pass surgery, angioplasty with or without stent placement, etc.) as confirmed by a cardiologist will be permitted. In addition, patients with documented or presumed unstable coronary artery disease, stable or unstable cardiovascular disease or cerebrovascular disease, or second or third degree heart block should not be enrolled.
  18. History of uncontrolled severe seizure disorder.
  19. Evidence of an active or suspected cancer, or a history of malignancy within the last 2 years, with the exception of patients with basal cell carcinoma that has been excised and cured.
  20. Poorly controlled thyroid dysfunction.
  21. History or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy (e.g., cytomegalovirus, macular degeneration).
  22. History of major organ transplantation with an existing functional graft.
  23. History or other evidence of severe illness, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
  24. Any herbal supplements containing silymarin, tocopherol, vitamin C, bioflavins, curcumin. For complete list see appendix.3
  25. Consumption of any nutrients know to possess antioxidant activity
  26. Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of first dose.

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 identifier (NCT number): NCT01511523

United States, North Carolina
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States, 28304
Sponsors and Collaborators
Biovil Research Group, LLC
Principal Investigator: John Poulos, MD Cumberland Research Associates

Responsible Party: Biovil Research Group, LLC Identifier: NCT01511523     History of Changes
Other Study ID Numbers: BVL-001
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: January 2012

Keywords provided by Biovil Research Group, LLC:
Non Alcoholic
Vitamin E

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases