Is Omega-3 Fatty Acid Red Blood Cell (RBC) Saturation Product Dependent?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bucci Laser Vision Institute
ClinicalTrials.gov Identifier:
NCT01091714
First received: March 18, 2010
Last updated: October 4, 2011
Last verified: October 2011

March 18, 2010
October 4, 2011
October 2010
July 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01091714 on ClinicalTrials.gov Archive Site
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Is Omega-3 Fatty Acid Red Blood Cell (RBC) Saturation Product Dependent?
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardioprotective Levels
  • Dietary Supplement: Omega-3
    Approximately 2400 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
  • Dietary Supplement: Omega-3
    Approximately 2240 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
  • Dietary Supplement: Omega-3
    Approximately 2332 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
  • Active Comparator: PRN Dry Eye Omega Benefits
    4 capsules per day = 2240 mg Omega-3s
    Intervention: Dietary Supplement: Omega-3
  • Active Comparator: Nature's Made
    2 capsules per day = 2400mg Omega-3s
    Intervention: Dietary Supplement: Omega-3
  • Active Comparator: Thera Tears
    4 capsules per day = 2332mg Omega-3s
    Intervention: Dietary Supplement: Omega-3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01091714
01-2010
No
Bucci Laser Vision Institute
Bucci Laser Vision Institute
Not Provided
Principal Investigator: Frank A Bucci, Jr., MD Bucci Laser Vision Institute
Bucci Laser Vision Institute
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP