Is Omega-3 Fatty Acid Red Blood Cell (RBC) Saturation Product Dependent?
Is Omega-3 Fatty Acid RBC Saturation Product Dependent?
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 24, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedOctober 5, 2011
October 1, 2011
9 months
March 18, 2010
October 4, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
one month
Secondary Outcomes (1)
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
3 months
Study Arms (3)
PRN Dry Eye Omega Benefits
ACTIVE COMPARATOR4 capsules per day = 2240 mg Omega-3s
Nature's Made
ACTIVE COMPARATOR2 capsules per day = 2400mg Omega-3s
Thera Tears
ACTIVE COMPARATOR4 capsules per day = 2332mg Omega-3s
Interventions
Approximately 2400 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank A Bucci, Jr., MD
Bucci Laser Vision Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 24, 2010
Study Start
October 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
October 5, 2011
Record last verified: 2011-10