Cardioprotective LevelsPhase 4NCT01091714
Is Omega-3 Fatty Acid Red Blood Cell (RBC) Saturation Product Dependent?
A Phase 4 study testing Omega-3 in people with Cardioprotective Levels, run by Bucci Laser Vision Institute at 1 site in United States.
Trial summary
To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardioprotective Levels
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent.
- Subject motivation and willingness to cooperate with the investigator by following the required medication regimen.
- Subject willingness and ability to return for all visits during the study.
- Must be willing to discontinue all use of Omega-3 supplementation 2 weeks prior to study participation.
Who cannot join
- Concurrent involvement in any other clinical trial involving an investigational drug or device.
- Compromised cognitive ability which may be expected to interfere with study compliance.
- Uncontrolled or poorly controlled systemic disease ot the presence of any significant illness that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study.
- Subjects must not eat more that 1 non-fried fish meal per week.
- Subjects must not have undergone any bariatric surgery or have a malabsorption disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: Is Omega-3 Fatty Acid RBC Saturation Product Dependent?
To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study.
Read the detailed description
To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study. The HS-Omega-3 Index is a new test that measures blood levels of the cardioprotective omega-3 fatty acids, EPA and DHA. RBS saturation is being measured to identify how much Omega 3 is in the blood.
- Conditions
- Cardioprotective Levels
- Being tested
- Omega-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Approximately 2400 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
Omega-3Dietary supplement
Approximately 2240 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
Omega-3Dietary supplement
Approximately 2332 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| PRN Dry Eye Omega Benefits | Active comparator | 4 capsules per day = 2240 mg Omega-3s Receives: Dietary Supplement: Omega-3 |
| Nature's Made | Active comparator | 2 capsules per day = 2400mg Omega-3s Receives: Dietary Supplement: Omega-3 |
| Thera Tears | Active comparator | 4 capsules per day = 2332mg Omega-3s Receives: Dietary Supplement: Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
Measured: one month
Secondary outcomes (1)
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardioprotective LevelsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucci Laser Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank A Bucci, Jr., MD, Principal investigator, Bucci Laser Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091714
- Sponsor's protocol ID
- 01-2010
- Status last verified
- Oct 2011
- First submitted
- 18 Mar 2010
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Omega-3 Fatty Acid RBC Saturation Product Dependent?
- ClinicalTrials.gov ID
- NCT01091714
- Acronym / sponsor ID
- 01-2010
- Conditions
- Cardioprotective Levels
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bucci Laser Vision InstituteUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Mar 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 demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study.
Detailed description
To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study. The HS-Omega-3 Index is a new test that measures blood levels of the cardioprotective omega-3 fatty acids, EPA and DHA. RBS saturation is being measured to identify how much Omega 3 is in the blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRN Dry Eye Omega Benefits | Active comparator | Dietary Supplement: Omega-34 capsules per day = 2240 mg Omega-3s |
| Nature's Made | Active comparator | Dietary Supplement: Omega-32 capsules per day = 2400mg Omega-3s |
| Thera Tears | Active comparator | Dietary Supplement: Omega-34 capsules per day = 2332mg Omega-3s |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to give written informed consent.
- Subject motivation and willingness to cooperate with the investigator by following the required medication regimen.
- Subject willingness and ability to return for all visits during the study.
- Must be willing to discontinue all use of Omega-3 supplementation 2 weeks prior to study participation.
Key exclusion criteria (5 listed)
- Concurrent involvement in any other clinical trial involving an investigational drug or device.
- Compromised cognitive ability which may be expected to interfere with study compliance.
- Uncontrolled or poorly controlled systemic disease ot the presence of any significant illness that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study.
- Subjects must not eat more that 1 non-fried fish meal per week.
- Subjects must not have undergone any bariatric surgery or have a malabsorption disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Approximately 2400 mg of Omega-3s taken once daily by capsule, taken for the duration of the study. | Dietary supplement | Nature's Made |
| Omega-3Approximately 2240 mg of Omega-3s taken once daily by capsule, taken for the duration of the study. | Dietary supplement | PRN Dry Eye Omega Benefits |
| Omega-3Approximately 2332 mg of Omega-3s taken once daily by capsule, taken for the duration of the study. | Dietary supplement | Thera Tears |
Primary outcome
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
Time frame: one month
1 secondary outcome
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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.
Frank A Bucci, Jr., MD principal investigator
Bucci Laser Vision Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 in people with Cardioprotective Levels, run by Bucci Laser Vision Institute at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test. (time frame: one month). It is what the study was designed to measure, not a finding.
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 5 Oct 2011.