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Effect of Omega-3 Fatty Acid on Endothelial Function

Primary Purpose

Familial Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Omega-3
placebo
Sponsored by
Nordlandssykehuset HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Familial Hypercholesterolemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Internal Medicine, Nordland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omega-3

Placebo

Arm Description

Omega-3 fatty acids

Placebo/olive oil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2013
Last Updated
May 10, 2019
Sponsor
Nordlandssykehuset HF
Collaborators
Pronova BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT01813006
Brief Title
Effect of Omega-3 Fatty Acid on Endothelial Function
Official Title
Effect of Omega-3 Polyunsaturated Fat on Endothelial Function and Inflammatory Parameters in Familial Hypercholesterolemia - a Double Blind, Placebo-controlled Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordlandssykehuset HF
Collaborators
Pronova BioPharma

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Active Comparator
Arm Description
Omega-3 fatty acids
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo/olive oil
Intervention Type
Drug
Intervention Name(s)
Omega-3
Other Intervention Name(s)
Omacor
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
olive oil
Primary Outcome Measure Information:
Title
Reactive Hyperemia Index (RHI)
Description
Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry
Time Frame
Baseline
Title
Reactive Hyperemia Index (RHI)
Description
Measure of endothelial function
Time Frame
3 months
Title
Reactive Hyperemia Index (RHI)
Description
Measure of endothelial function
Time Frame
6 months
Title
Reactive Hyperemia Index (RHI)
Description
Measure of endothelial function
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Markers of inflammation
Description
Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors
Time Frame
Baseline
Title
Inflammatory markers
Description
Serological markers of inflammation including cytokines, CRP and complement factors
Time Frame
3 months
Title
Inflammatory markers
Description
Serological markers of inflammation including cytokines, CRP and complement factors
Time Frame
6 months
Title
Inflammatory markers
Description
Serological markers of inflammation including cytokines, CRP and complement factors
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Lipid parameters
Description
Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions
Time Frame
Baseline
Title
Lipid parameters
Description
Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions
Time Frame
3 months
Title
Lipid parameters
Description
Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions
Time Frame
6 months
Title
Lipid parameters
Description
Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut T Lappegård, MD, PhD
Organizational Affiliation
Nordland Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Internal Medicine, Nordland Hospital
City
Bodø
ZIP/Postal Code
8011
Country
Norway

12. IPD Sharing Statement

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Effect of Omega-3 Fatty Acid on Endothelial Function

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