HealthyNCT01221714
Toxicity and Safety Evaluation of an Omega-3 Fatty Acid and a Multivitamin and Antioxidant Nutritional Preparation
An observational study of Healthy, run by AmeriSciences LP at 3 sites in United States.
Trial summary
To evaluate the safety and tolerability of two supplements in healthy subjects taken daily for six months. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 160-200 healthy volunteers at five to six study centers (25-50) per center) will be evaluated.
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carolina Medical Associates
Charlotte, North Carolina, 28226
Logan General Hospital
Logan, West Virginia, 25601
Mississippi Family Doctors
Pearl, Mississippi, 39208
About this study
To evaluate the safety and tolerability of two supplements in healthy subjects taken daily for six months.
Read the 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.
- Conditions
- Healthy
- Keywords
- nutritional supplements, supplements, vitamins, omega-3, Amerisciences, Carlos Montesinos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active/Placebo | ACTIVE VITAMIN; PLACEBO OMEGA MAX | |
| Active/Active | ACTIVE VITAMIN; ACTIVE OMEGA MAX | |
| Placebo/Active | PLACEBO VITAMIN; ACTIVE OMEGA MAX | |
| Placebo/Placebo | PLACEBO VITAMIN; PLACEBO OMEGA MAX |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Ameriscience went bankrupt.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AmeriSciences LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio-Medical Consultants, Inc., Vantage Data Solutions Inc., Esoterix, Inc., Dr. Marwan Sabbagh, Study Monitor
- Investigators
- Carlos Montesinos, Principal investigator, AmeriSciences LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221714
- Sponsor's protocol ID
- AS08-001
- Status last verified
- Jan 2018
- First submitted
- 14 Oct 2010
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxicity and Safety Evaluation of an Omega-3 Fatty Acid and a Multivitamin and Antioxidant Nutritional Preparation
- ClinicalTrials.gov ID
- NCT01221714
- Acronym / sponsor ID
- AS08-001
- Conditions
- Healthy
- Keywords
- nutritional supplements, supplements, vitamins, omega-3, Amerisciences, Carlos Montesinos
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Ameriscience went bankrupt.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AmeriSciences LPIndustry (pharma, biotech, devices)
- Collaborators
- Bio-Medical Consultants, Inc., Vantage Data Solutions Inc., Esoterix, Inc., Dr. Marwan Sabbagh, Study Monitor
- Study start
- Oct 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active/Placebo | – | –ACTIVE VITAMIN; PLACEBO OMEGA MAX |
| Active/Active | – | –ACTIVE VITAMIN; ACTIVE OMEGA MAX |
| Placebo/Active | – | –PLACEBO VITAMIN; ACTIVE OMEGA MAX |
| Placebo/Placebo | – | –PLACEBO VITAMIN; PLACEBO OMEGA MAX |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 160-200 healthy volunteers at five to six study centers (25-50) per center) will be evaluated.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Ameriscience went bankrupt.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Montesinos principal investigator
AmeriSciences LP
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by AmeriSciences LP at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Ameriscience went bankrupt.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.