- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00924274
Effect of Rapeseed Oil and Sunflower Oil
June 17, 2009 updated by: Medical University of Vienna
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
-
Contact:
- Marika Miklautsch, Mag.
- Phone Number: 2051 0043 40 400
- Email: marika.miklautsch@meduniwien.ac.at
-
Contact:
- Marika Miklautsch
-
Principal Investigator:
- Marika Miklautsch, Mag.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- overweight
- underweight
- mental disability
- drug therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lifestyle counseling
|
rapeseed oil in amounts between 14 and 27 g
|
ACTIVE_COMPARATOR: sunflower oil
|
sunflower oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
done in Week 1, Week 7, Week 13
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motivation, compliance, increase of quality of life.
Time Frame: done in Week 1 and Week 13
|
done in Week 1 and Week 13
|
Acceptance and approach to the disease.
Time Frame: done in Week 1 and Week 13
|
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
|
done in Week 1 and Week 13
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ANTICIPATED)
July 1, 2010
Study Completion (ANTICIPATED)
December 1, 2010
Study Registration Dates
First Submitted
June 17, 2009
First Submitted That Met QC Criteria
June 17, 2009
First Posted (ESTIMATE)
June 18, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 18, 2009
Last Update Submitted That Met QC Criteria
June 17, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EROSO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Familial Hypercholesterolemia
-
National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
-
Regeneron PharmaceuticalsSanofiTerminatedHeterozygous Familial Hypercholesterolemia | Non-familial HypercholesterolemiaUnited States, Bulgaria, Estonia, Russian Federation, South Africa, Ukraine
-
Merck Sharp & Dohme LLCTerminatedHypercholesterolemia, Familial | Heterozygous Familial Hypercholesterolemia
-
Institut Investigacio Sanitaria Pere VirgiliRecruitingFamilial Hypercholesterolemia | Familial Hypercholesterolemia - Homozygous | Familial Hypercholesterolemia - HeterozygousSpain
-
Novartis PharmaceuticalsActive, not recruitingFamilial Hypercholesterolemia - HomozygousGreece, Lebanon, Turkey, France, Canada, Malaysia, Netherlands, United States
-
Novartis PharmaceuticalsRecruitingHeterozygous or Homozygous Familial HypercholesterolemiaNetherlands, Israel, Hungary, Italy, Germany, Spain, France, Norway, South Africa, Turkey, United Kingdom, Canada, Switzerland, Brazil, Lebanon, Slovenia, United States, Russian Federation, Taiwan
-
Novartis PharmaceuticalsCompletedElevated Cholesterol | Homozygous Familial Hypercholesterolemia | Heterozygous Familial Hypercholesterolemia | ASCVDUnited States, Canada, Czechia, Denmark, Germany, Hungary, Netherlands, Poland, South Africa, Spain, Sweden, Ukraine, United Kingdom
-
REGENXBIO Inc.National Heart, Lung, and Blood Institute (NHLBI)TerminatedHomozygous Familial Hypercholesterolemia (HoFH)United States, Canada, Italy, Netherlands
-
University of British ColumbiaVancouver Coastal Health Research Institute; Genome British ColumbiaRecruitingAcute Coronary Syndrome | Familial Hypercholesterolemia | STEMI | NSTEMI - Non-ST Segment Elevation MI | Familial Hypercholesterolemia - Heterozygous | Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B | Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation and other conditionsCanada
-
Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
Clinical Trials on rapeseed oil
-
Rigshospitalet, DenmarkDanish Child Cancer FoundationRecruitingLeukemia, Acute LymphoblasticDenmark
-
King's College LondonCompleted
-
Kanta-Häme Central HospitalLinnan Klinikka Oy; Finnish Red Cross Blood Service; MTT Agrifood Research FinlandCompleted
-
Medical University of ViennaUnknown
-
University Hospital, Clermont-FerrandUnilever R&D; Lesieur; Centre de Recherche en Nutrition Humaine d'Auvergne; ITERG; Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementCompletedCardiovascular DiseasesFrance
-
University of GlasgowCompletedCardiovascular DiseasesUnited Kingdom
-
University of CopenhagenDanish Research Agency; Technical University of Denmark; HjerteforeningenUnknownMetabolic Syndrome | Cardiovascular Heart DiseaseDenmark
-
Assistance Publique - Hôpitaux de ParisITERG; Institut Elevage; SAINT HUBERT; TERRES UNIVIA; TERRES INOVIACompletedCardiovascular Diseases | Inflammation | Metabolism Disorder, LipidFrance
-
King's College LondonCompletedHealthy Adults | Postmenopausal WomenUnited Kingdom
-
Avena Nordic Grain OyCompleted