Effect of Rapeseed Oil and Sunflower Oil | NCT00924274

Studies
Effect of Rapeseed Oil and Sunflower Oil

NCT00924274

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Jun 18, 2009Estimated

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Familial Hypercholesterolemia

Interventions

rapeseed oil
sunflower oil

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jul 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jun 17, 2009

First Submission Date that Met QC Criteria

Jun 17, 2009

First Posted Date

Jun 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2009

Last Update Posted Date

Jun 18, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle counseling	Experimental		Dietary Supplement: rapeseed oil
sunflower oil	Active Comparator		Dietary Supplement: sunflower oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rapeseed oil	Dietary Supplement	rapeseed oil in amounts between 14 and 27 g	Lifestyle counseling

Outcomes Module

Primary Outcomes

Measure	Description	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.		done in Week 1, Week 7, Week 13

Secondary Outcomes

Measure	Description	Time Frame
Motivation, compliance, increase of quality of life.		done in Week 1 and Week 13
Acceptance and approach to the disease.		done in Week 1 and Week 13
Improvement of knowledge and understanding about the disease by the patients.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna	Recruiting	Vienna	State of Vienna	1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D006938	Hyperlipoproteinemia Type II

Ancestor Terms

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074262	Rapeseed Oil
D000074242	Sunflower Oil

Ancestor Terms

ID	Term
D010938	Plant Oils
D009821	Oils
D008055	Lipids
D028321	Plant Preparations
D001688

Browse Leaves

Not provided

Browse Branches

Not provided