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

March 14, 2013
March 14, 2013
March 2013
December 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
  • 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
Same as current
  • 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
Same as current
 
Effect of Omega-3 Fatty Acid on Endothelial Function
Effect of Omega-3 Polyunsaturated Fat on Endothelial Function and Inflammatory Parameters in Familial Hypercholesterolemia - a Double Blind, Placebo-controlled Crossover Study

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Familial Hypercholesterolemia
  • Drug: Omega-3
    Other Name: Omacor
  • Drug: placebo
    Other Name: olive oil
  • Active Comparator: Omega-3
    Omega-3 fatty acids
    Intervention: Drug: Omega-3
  • Placebo Comparator: Placebo
    Placebo/olive oil
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Knut T Lappegård, MD, PhD 004775534000 knut.tore.lappegard@gmail.com
Contact: Anders W Hovland, MD, PhD 004775534000 anders.w.hovland@gmail.com
Norway
 
NCT01813006
2011/899(REK), 2012-000505-68
No
Nordlandssykehuset HF
Nordlandssykehuset HF
Pronova BioPharma
Principal Investigator: Knut T Lappegård, MD, PhD Nordland Hospital
Nordlandssykehuset HF
March 2013

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