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Effect of Rapeseed Oil and Sunflower Oil

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. 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
Information provided by:
Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE June 17, 2009
First Posted Date  ICMJE June 18, 2009
Last Update Posted Date June 18, 2009
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of Rapeseed Oil and Sunflower Oil
Official Title  ICMJE Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Familial Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: rapeseed oil
    rapeseed oil in amounts between 14 and 27 g
  • Dietary Supplement: sunflower oil
    sunflower oil
Study Arms  ICMJE
  • Experimental: Lifestyle counseling
    Intervention: Dietary Supplement: rapeseed oil
  • Active Comparator: sunflower oil
    Intervention: Dietary Supplement: sunflower oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2009)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00924274
Other Study ID Numbers  ICMJE EROSO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kurt Widhalm/Prof., Devision Nutrition and Metabolsim, Medical University of Vienna
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of Vienna
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP