Effect of Omega-3 Fatty Acid on Endothelial Function

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Nordlandssykehuset HF
Sponsor:
Collaborator:
Pronova BioPharma
Information provided by (Responsible Party):
Nordlandssykehuset HF
ClinicalTrials.gov Identifier:
NCT01813006
First received: March 14, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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 Intervention Phase
Familial Hypercholesterolemia
Drug: Omega-3
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Nordlandssykehuset HF:

Primary Outcome Measures:
  • Reactive Hyperemia Index (RHI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry

  • Reactive Hyperemia Index (RHI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measure of endothelial function

  • Reactive Hyperemia Index (RHI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure of endothelial function

  • Reactive Hyperemia Index (RHI) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Measure of endothelial function


Secondary Outcome Measures:
  • Markers of inflammation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors

  • Inflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Serological markers of inflammation including cytokines, CRP and complement factors

  • Inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Serological markers of inflammation including cytokines, CRP and complement factors

  • Inflammatory markers [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Serological markers of inflammation including cytokines, CRP and complement factors


Other Outcome Measures:
  • Lipid parameters [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

  • Lipid parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

  • Lipid parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

  • Lipid parameters [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omega-3
Omega-3 fatty acids
Drug: Omega-3
Other Name: Omacor
Placebo Comparator: Placebo
Placebo/olive oil
Drug: placebo
Other Name: olive oil

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813006

Contacts
Contact: Knut T Lappegård, MD, PhD 004775534000 knut.tore.lappegard@gmail.com
Contact: Anders W Hovland, MD, PhD 004775534000 anders.w.hovland@gmail.com

Locations
Norway
Division of Internal Medicine, Nordland Hospital Recruiting
Bodø, Norway, 8011
Contact: Knut T Lappegård, MD, PhD    004775534000    knut.tore.lappegard@gmail.com   
Contact: Anders W Hovland, MD, PhD    004775534000    anders.w.hovland@gmail.com   
Principal Investigator: Knut T Lappegård, MD, PhD         
Sub-Investigator: Anders W Hovland, MD, PhD         
Sponsors and Collaborators
Nordlandssykehuset HF
Pronova BioPharma
Investigators
Principal Investigator: Knut T Lappegård, MD, PhD Nordland Hospital
  More Information

No publications provided

Responsible Party: Nordlandssykehuset HF
ClinicalTrials.gov Identifier: NCT01813006     History of Changes
Other Study ID Numbers: 2011/899(REK), 2012-000505-68
Study First Received: March 14, 2013
Last Updated: March 14, 2013
Health Authority: Norway: The National Committee for Medical and Health Research Ethics in Norway
Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on July 29, 2014