Familial HypercholesterolemiaPhase 3NCT01813006
Effect of Omega-3 Fatty Acid on Endothelial Function
A Phase 3 study testing Omega-3 in people with Familial Hypercholesterolemia, run by Nordlandssykehuset HF at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2013to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- documented familial hypercholesterolemia
- age 18-60 years
- on statin treatment for at least 12 months
Who cannot join
- pregnancy or planned pregnancy
- breast feeding
- cancer
- non-compliance
- PUFA/omega-3 < 3 months before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Omega-3, placebo
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Drug
Also called Omacor
placeboDrug
Also called olive oil
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Active comparator | Omega-3 fatty acids Receives: Drug: Omega-3 |
| Placebo | Placebo comparator | Placebo/olive oil Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Hyperemia Index (RHI)
Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry
Measured: Baseline
Reactive Hyperemia Index (RHI)
Measure of endothelial function
Measured: 3 months
Reactive Hyperemia Index (RHI)
Measure of endothelial function
Measured: 6 months
Reactive Hyperemia Index (RHI)
Measure of endothelial function
Measured: 9 months
Secondary outcomes (4)
Markers of inflammation
Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors
Measured: Baseline
Inflammatory markers
Serological markers of inflammation including cytokines, CRP and complement factors
Measured: 3 months
Inflammatory markers
Serological markers of inflammation including cytokines, CRP and complement factors
Measured: 6 months
Inflammatory markers
Serological markers of inflammation including cytokines, CRP and complement factors
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- Pronova BioPharma
- Responsible party
- Sponsor
- Investigators
- Knut T Lappegård, MD, PhD, Principal investigator, Nordland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813006
- Sponsor's protocol ID
- 2011/899(REK)
- Other IDs
- 2012-000505-68
- Status last verified
- Mar 2013
- First submitted
- 14 Mar 2013
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36999528
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega-3 Polyunsaturated Fat on Endothelial Function and Inflammatory Parameters in Familial Hypercholesterolemia - a Double Blind, Placebo-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT01813006
- Acronym / sponsor ID
- 2011/899(REK)
- Conditions
- Familial Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- Pronova BioPharma
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Active comparator | Drug: Omega-3Omega-3 fatty acids |
| Placebo | Placebo comparator | Drug: placeboPlacebo/olive oil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- documented familial hypercholesterolemia
- age 18-60 years
- on statin treatment for at least 12 months
Key exclusion criteria (5 listed)
- pregnancy or planned pregnancy
- breast feeding
- cancer
- non-compliance
- PUFA/omega-3 < 3 months before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Also: Omacor | Drug | Omega-3 |
| placeboAlso: olive oil | Drug | Placebo |
Primary outcome
Reactive Hyperemia Index (RHI)
Time frame: Baseline
Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry
Reactive Hyperemia Index (RHI)
Time frame: 3 months
Measure of endothelial function
Reactive Hyperemia Index (RHI)
Time frame: 6 months
Measure of endothelial function
Reactive Hyperemia Index (RHI)
Time frame: 9 months
Measure of endothelial function
4 secondary outcomes
Markers of inflammation
Time frame: Baseline
Inflammatory markers
Time frame: 3 months
Inflammatory markers
Time frame: 6 months
Inflammatory markers
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Derived from this study: PubMed 36999528Hande 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut T Lappegård, MD, PhD principal investigator
Nordland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 in people with Familial Hypercholesterolemia, run by Nordlandssykehuset HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive Hyperemia Index (RHI) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01813006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.