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

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: NCT01221714
Recruitment Status : Terminated (Ameriscience went bankrupt.)
First Posted : October 15, 2010
Last Update Posted : January 24, 2018
Bio-Medical Consultants, Inc.
Vantage Data Solutions Inc.
Esoterix, Inc.
Dr. Marwan Sabbagh, Study Monitor
Information provided by:
AmeriSciences LP

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

Condition or disease

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 the development of nutritional products in the form of dietary supplements to maintain homeostasis, and as countermeasures to reduce the biological effects and damages of long-duration spaceflight mediated through oxidative stress both in low Earth Orbit and planetary exploration of the solar system, as well as to provide optimal nutritional supplementation to aid in pre-spaceflight conditioning.

NASA has determined through pre-, in-, and post-flight assessment of cells, animals and humans that spaceflight induces oxidative stress on crewmembers. There are multiple potential sources of oxidative injury to include, but not limited to space radiation, noise, fuel reaction products, planetary regolith, and exercise. Furthermore, NASA has also determined that several foreseen and unforeseen physiological events can be controlled, avoided, or encouraged by means of dietary modification through supplements. Due to unforeseen limitation in the available fresh food supply for envisioned exploratory missions, it is desirable for NASA to have nutritional supplementation available to provide crewmembers with augmentation for the intrinsic defense systems against oxidative damage, as well as for potential nutritional contingencies such as food shortages and optimization of the diet. NASA has identified the need for specific micronutrient formulations to complement natural food sources, for astronaut protection during long-duration space flight.

AmeriSciences is a nutritional company that specializes in science-based product formulation, manufacturing under Good Manufacturing Practices (GMP) using standards modeled after those used by the pharmaceutical industry. It has been charged with the co-development, aid, clinical evaluation, construction, and production of said micronutrient formulations, to the level of specifications required to meet NASA's expectations for safety and efficacy.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Toxicity and Safety Evaluation of an Omega-3 Fatty Acid and a Multivitamin and Antioxidant Nutritional Preparation
Study Start Date : October 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants


Biospecimen Retention:   Samples Without DNA
Blood samples will be drawn at baseline and three months to monitor hematology, blood chemistry, and urinalysis values for major changes. CBC, Chem-17, uric acid, lipid panel, PT/PTT, and urinalysis will be evaluated under fasting conditions.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 160-200 healthy volunteers at five to six study centers (25-50) per center) will be evaluated.

Inclusion Criteria:

To be eligible, patients must meet the following eligibility criteria:

  1. Male or Female subject between the ages of 21 and 65 years
  2. Capable of providing informed consent
  3. 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.
  4. Patients who usually and customarily take dietary supplements, including vitamins, must undergo a two-week washout period

Exclusion Criteria:

To be eligible, patients must not meet any of the following exclusion criteria:

  1. Exposure to any investigational drug within 90 days of the beginning of this study
  2. 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.
  3. History of cancer within the last 5 years, except for basal or squamous cell cancer.
  4. Allergy to fish (specifically sardines, anchovies or mackerel) or any of the investigational product components
  5. Concomitant use, or use within less than a two-week period, of any other dietary supplement
  6. Concomitant use of any drug known to interfere with laboratory measures such as:

    1. Niaspan (extended release niacin)
    2. Lamisil (terbinafine HCl)
    3. Chronic use of acetaminophen (>1,500 mg/day) (occasional use for minor aches and pains is excluded from this restriction)
    4. New prescriptions (< 90days) of HMG-CoA reductase inhibitors ("statins"), or patients currently on statins who have previously shown evidence of elevated serum transaminases
  7. Currently diagnosed with multiple sclerosis, systemic lupus erythematosis, or other autoimmune disorders known to interfere with laboratory measures
  8. Pregnancy, Lactation, or females actively attempting to become pregnant
  9. History of alcoholism or drug abuse, unless it is determined that such past use would not influence laboratory measures (DSN4 criteria)
  10. 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
  11. Conditions that require nutritional therapy, such as:

    1. Pernicious anemia
    2. Iron-deficiency anemia
    3. Hartnup Disease or Pellagra
    4. Scurvy
    5. Beriberi-induced Endemic Neuritis

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): NCT01221714

United States, Mississippi
Mississippi Family Doctors
Pearl, Mississippi, United States, 39208
United States, North Carolina
Carolina Medical Associates
Charlotte, North Carolina, United States, 28226
United States, West Virginia
Logan General Hospital
Logan, West Virginia, United States, 25601
Sponsors and Collaborators
AmeriSciences LP
Bio-Medical Consultants, Inc.
Vantage Data Solutions Inc.
Esoterix, Inc.
Dr. Marwan Sabbagh, Study Monitor
Principal Investigator: Carlos Montesinos AmeriSciences LP

Responsible Party: Carlos A. Montesinos/Director of Quality and Product Development, AmeriSciences Identifier: NCT01221714     History of Changes
Other Study ID Numbers: AS08-001
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Keywords provided by AmeriSciences LP:
nutritional supplements
Carlos Montesinos

Additional relevant MeSH terms:
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents