Clincosm LogoSign in Get a demo

Effect of Omega-3 Fatty Acid on Endothelial Function

Sponsor
Nordlandssykehuset HF (Other)
Overall Status
Completed
CT.gov ID
NCT01813006
Collaborator
Pronova BioPharma (Industry)
34
Enrollment
1
Location
2
Arms
57
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background

Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with FH is not known.

The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to inflammation measured in the blood and the effect on the blood vessels'ability to relax (endothelial function) by means of tonometry.

Hypothesis

Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Omega-3 Polyunsaturated Fat on Endothelial Function and Inflammatory Parameters in Familial Hypercholesterolemia - a Double Blind, Placebo-controlled Crossover Study
Actual Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Omega-3

Omega-3 fatty acids

Drug: Omega-3
Other Names:
  • Omacor

    		•
    Placebo Comparator: Placebo

    Placebo/olive oil

    Drug: placebo
    Other Names:
  • olive oil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reactive Hyperemia Index (RHI) [Baseline]

      Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry

    2. Reactive Hyperemia Index (RHI) [3 months]

      Measure of endothelial function

    3. Reactive Hyperemia Index (RHI) [6 months]

      Measure of endothelial function

    4. Reactive Hyperemia Index (RHI) [9 months]

      Measure of endothelial function

    Secondary Outcome Measures

    1. Markers of inflammation [Baseline]

      Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors

    2. Inflammatory markers [3 months]

      Serological markers of inflammation including cytokines, CRP and complement factors

    3. Inflammatory markers [6 months]

      Serological markers of inflammation including cytokines, CRP and complement factors

    4. Inflammatory markers [9 months]

      Serological markers of inflammation including cytokines, CRP and complement factors

    Other Outcome Measures

    1. Lipid parameters [Baseline]

      Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

    2. Lipid parameters [3 months]

      Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

    3. Lipid parameters [6 months]

      Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

    4. Lipid parameters [9 months]

      Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • documented familial hypercholesterolemia

    • age 18-60 years

    • on statin treatment for at least 12 months

    Exclusion Criteria:

    • pregnancy or planned pregnancy

    • breast feeding

    • cancer

    • non-compliance

    • PUFA/omega-3 < 3 months before inclusion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Internal Medicine, Nordland Hospital Bodø Norway 8011

    Sponsors and Collaborators

    • Nordlandssykehuset HF
    • Pronova BioPharma

    Investigators

    • Principal Investigator: Knut T Lappegård, MD, PhD, Nordland Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nordlandssykehuset HF
    ClinicalTrials.gov Identifier:
    NCT01813006
    Other Study ID Numbers:
    • 2011/899(REK)
    • 2012-000505-68
    First Posted:
    Mar 18, 2013
    Last Update Posted:
    May 13, 2019
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Hyperlipoproteinemia Type II
    Hypercholesterolemia

    Study Results

    No Results Posted as of May 13, 2019