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Effect of Rapeseed Oil and Sunflower Oil

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Medical University of Vienna.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: June 18, 2009
Last Update Posted: June 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
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.

Condition Intervention
Familial Hypercholesterolemia Dietary Supplement: rapeseed oil Dietary Supplement: sunflower oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: March 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling Dietary Supplement: rapeseed oil
rapeseed oil in amounts between 14 and 27 g
Active Comparator: sunflower oil Dietary Supplement: sunflower oil
sunflower oil


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924274

Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Marika Miklautsch, Mag.    0043 40 400 ext 2051    marika.miklautsch@meduniwien.ac.at   
Contact: Marika Miklautsch         
Principal Investigator: Marika Miklautsch, Mag.         
Sponsors and Collaborators
Medical University of Vienna
  More Information

Responsible Party: Kurt Widhalm/Prof., Devision Nutrition and Metabolsim, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00924274     History of Changes
Other Study ID Numbers: EROSO
First Submitted: June 17, 2009
First Posted: June 18, 2009
Last Update Posted: June 18, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn