Status:
TERMINATED
Toxicity and Safety Evaluation of an Omega-3 Fatty Acid and a Multivitamin and Antioxidant Nutritional Preparation
Lead Sponsor:
AmeriSciences LP
Collaborating Sponsors:
Bio-Medical Consultants, Inc.
Vantage Data Solutions Inc.
Conditions:
Healthy
Eligibility:
All Genders
21-65 years
Brief Summary
To evaluate the safety and tolerability of two supplements in healthy subjects taken daily for six months.
Detailed Description
The Lyndon B. Johnson Space Center (JSC) of the National Aeronautics and Space Administration (NASA) and AmeriSciences have entered into a Space Act Agreement (1), the primary objectives of which are ...
Eligibility Criteria
Inclusion
- To be eligible, patients must meet the following eligibility criteria:
- Male or Female subject between the ages of 21 and 65 years
- Capable of providing informed consent
- Patients currently taking HMG-CoA reductase inhibitors (i.e. "statin" drugs), or any other drug known to interfere with serum transaminase (i.e. liver enzymes), must have history of stable liver function test since first taking such drugs.
- Patients who usually and customarily take dietary supplements, including vitamins, must undergo a two-week washout period
Exclusion
- To be eligible, patients must not meet any of the following exclusion criteria:
- Exposure to any investigational drug within 90 days of the beginning of this study
- Known human immunodeficiency virus (HIV) seropositivity or Acquired Immunodeficiency Syndrome (AIDS); history of Hepatitis B (HBV), Hepatitis C (HCV) vital infection, unexplained elevated serum transaminase, or other hepatic disease. NOTE: HIV, HCV and HBV testing will not be performed as part of screening.
- History of cancer within the last 5 years, except for basal or squamous cell cancer.
- Allergy to fish (specifically sardines, anchovies or mackerel) or any of the investigational product components
- Concomitant use, or use within less than a two-week period, of any other dietary supplement
- Concomitant use of any drug known to interfere with laboratory measures such as:
- Niaspan (extended release niacin)
- Lamisil (terbinafine HCl)
- Chronic use of acetaminophen (\>1,500 mg/day) (occasional use for minor aches and pains is excluded from this restriction)
- New prescriptions (\< 90days) of HMG-CoA reductase inhibitors ("statins"), or patients currently on statins who have previously shown evidence of elevated serum transaminases
- Currently diagnosed with multiple sclerosis, systemic lupus erythematosis, or other autoimmune disorders known to interfere with laboratory measures
- Pregnancy, Lactation, or females actively attempting to become pregnant
- History of alcoholism or drug abuse, unless it is determined that such past use would not influence laboratory measures (DSN4 criteria)
- Any other active disease of a life-threatening nature or laboratory abnormality that, in the judgment of the investigator, may interfere with the interpretation, or increase risk of patient participation
- Conditions that require nutritional therapy, such as:
- Pernicious anemia
- Iron-deficiency anemia
- Hartnup Disease or Pellagra
- Scurvy
- Beriberi-induced Endemic Neuritis
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01221714
Start Date
October 1 2010
End Date
November 1 2013
Last Update
January 24 2018
Active Locations (3)
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1
Mississippi Family Doctors
Pearl, Mississippi, United States, 39208
2
Carolina Medical Associates
Charlotte, North Carolina, United States, 28226
3
Logan General Hospital
Logan, West Virginia, United States, 25601