Familial HypercholesterolemiaNCT00924274
Effect of Rapeseed Oil and Sunflower Oil
A study testing rapeseed oil and sunflower oil in people with Familial Hypercholesterolemia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- rapeseed oil and sunflower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2008to Dec 2010
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- chilren and adolescents between 6 and 18 years of age
- LDLc > 130 mg/dl and
- TC > 200 mg/dl
- 7 day nutrition record
- written informed consent
Who cannot join
- overweight
- underweight
- mental disability
- drug therapy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
Vienna, State of Vienna, 1090
Marika Miklautsch, Mag., 0043 40 400 ext. 2051, marika.miklautsch@meduniwien.ac.at
Marika Miklautsch
About this study
Official title: Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia
Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC). The purpose of this study is to compare the effect of a diet low in saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children and adolescents with FH on serum lipoproteins.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- rapeseed oil, sunflower oil
- 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.
rapeseed oilDietary supplement
rapeseed oil in amounts between 14 and 27 g
sunflower oilDietary supplement
sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Dietary Supplement: rapeseed oil |
| sunflower oil | Active comparator | Not described Receives: Dietary Supplement: sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood analysis including fasting serum lipoproteins (TC, LDLc; HDLc; TG, Lp(a), Apolipoprotein A-1, Apolipoprotein B, BB, hs-CRP, GOT, GPT, GGT, acid composition of plasma lipids.
Measured: done in Week 1, Week 7, Week 13
Secondary outcomes (3)
Motivation, compliance, increase of quality of life.
Measured: done in Week 1 and Week 13
Acceptance and approach to the disease.
Measured: done in Week 1 and Week 13
Improvement of knowledge and understanding about the disease by the patients.
Measured: done in Week 1 and Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startMar 2008
- Primary completionJul 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924274
- Sponsor's protocol ID
- EROSO
- Status last verified
- Jun 2009
- First submitted
- 17 Jun 2009
- Last updated
- 18 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00924274
- Acronym / sponsor ID
- EROSO
- Conditions
- Familial Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Jun 2009 (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.
Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC). The purpose of this study is to compare the effect of a diet low in saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children and adolescents with FH on serum lipoproteins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Dietary Supplement: rapeseed oil |
| sunflower oil | Active comparator | Dietary Supplement: sunflower oil |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- chilren and adolescents between 6 and 18 years of age
- LDLc > 130 mg/dl and
- TC > 200 mg/dl
- 7 day nutrition record
- written informed consent
Key exclusion criteria (4 listed)
- overweight
- underweight
- mental disability
- drug therapy
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 |
|---|---|---|
| rapeseed oilrapeseed oil in amounts between 14 and 27 g | Dietary supplement | Lifestyle counseling |
| sunflower oilsunflower oil | Dietary supplement | sunflower oil |
Primary outcome
Blood analysis including fasting serum lipoproteins (TC, LDLc; HDLc; TG, Lp(a), Apolipoprotein A-1, Apolipoprotein B, BB, hs-CRP, GOT, GPT, GGT, acid composition of plasma lipids.
Time frame: done in Week 1, Week 7, Week 13
3 secondary outcomes
Motivation, compliance, increase of quality of life.
Time frame: done in Week 1 and Week 13
Acceptance and approach to the disease.
Time frame: done in Week 1 and Week 13
Improvement of knowledge and understanding about the disease by the patients.
Time frame: done in Week 1 and Week 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2009.
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Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
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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.
Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapeseed oil and sunflower oil in people with Familial Hypercholesterolemia, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jun 2009. 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 Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood analysis including fasting serum lipoproteins (TC, LDLc; HDLc; TG, Lp(a), Apolipoprotein A-1, Apolipoprotein B, BB, hs-CRP, GOT, GPT, GGT, acid composition of plasma lipids. (time frame: done in Week 1, Week 7, Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2009.