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Effect of Rapeseed Oil and Sunflower Oil

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ClinicalTrials.gov Identifier: NCT00924274
Recruitment Status : Unknown
Verified June 2009 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : June 18, 2009
Last Update Posted : June 18, 2009
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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Brief 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). 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 or disease Intervention/treatment Phase
Familial Hypercholesterolemia Dietary Supplement: rapeseed oil Dietary Supplement: sunflower oil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Study Start Date : March 2008
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Motivation, compliance, increase of quality of life. [ Time Frame: done in Week 1 and Week 13 ]
  2. Acceptance and approach to the disease. [ Time Frame: done in Week 1 and Week 13 ]
  3. Improvement of knowledge and understanding about the disease by the patients. [ Time Frame: done in Week 1 and Week 13 ]

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

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
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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


Locations
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Austria
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
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Responsible Party: Kurt Widhalm/Prof., Devision Nutrition and Metabolsim, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00924274    
Other Study ID Numbers: EROSO
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias