Toxicity and Safety Evaluation of an Omega-3 Fatty Acid and a Multivitamin and Antioxidant Nutritional Preparation

Stopped early

Conditions studied: Healthy

In brief

To evaluate the safety and tolerability of two supplements in healthy subjects taken daily for six months.

Key facts

Study ID

NCT01221714

Run by

AmeriSciences LP

People needed

200

Starts

2010-10-01

Expected to finish

2013-11-01

Last updated by the study team

2018-01-24

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mississippi Family Doctors — Pearl, Mississippi, United States
• Carolina Medical Associates — Charlotte, North Carolina, United States
• Logan General Hospital — Logan, West Virginia, United States

Full record on ClinicalTrials.gov

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