NCT01813006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 13, 2019

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

March 14, 2013

Last Update Submit

May 10, 2019

Conditions

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (4)

  • Reactive Hyperemia Index (RHI)

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

    Baseline

  • Reactive Hyperemia Index (RHI)

    Measure of endothelial function

    3 months

  • Reactive Hyperemia Index (RHI)

    Measure of endothelial function

    6 months

  • Reactive Hyperemia Index (RHI)

    Measure of endothelial function

    9 months

Secondary Outcomes (4)

  • Markers of inflammation

    Baseline

  • Inflammatory markers

    3 months

  • Inflammatory markers

    6 months

  • Inflammatory markers

    9 months

Other Outcomes (4)

  • Lipid parameters

    Baseline

  • Lipid parameters

    3 months

  • Lipid parameters

    6 months

  • +1 more other outcomes

Study Arms (2)

Omega-3

ACTIVE COMPARATOR

Omega-3 fatty acids

Drug: Omega-3

Placebo

PLACEBO COMPARATOR

Placebo/olive oil

Drug: placebo

Interventions

Omega-3DRUG
Also known as: Omacor
Omega-3
placeboDRUG
Also known as: olive oil
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • documented familial hypercholesterolemia
  • age 18-60 years
  • on statin treatment for at least 12 months

You may not qualify if:

  • pregnancy or planned pregnancy
  • breast feeding
  • cancer
  • non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Internal Medicine, Nordland Hospital

Bodø, 8011, Norway

Location

Related Publications (1)

  • Hande LN, Thunhaug H, Ludviksen J, Hovland A, Lappegard KT. No effect of omega-3 polyunsaturated fatty acid supplementation on inflammatory markers in familial hypercholesterolemia: a randomized crossover trial. Scand J Clin Lab Invest. 2023 May;83(3):152-159. doi: 10.1080/00365513.2023.2178499. Epub 2023 Mar 31.

    PMID: 36999528DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Docosahexaenoic AcidsOmacorOlive Oil

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Knut T Lappegård, MD, PhD

    Nordland Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

May 13, 2019

Record last verified: 2013-03

Locations

NO(1)