Familial Hypercholesterolemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTrapeseed oil
rapeseed oil in amounts between 14 and 27 g
DIETARY_SUPPLEMENTsunflower oil
sunflower oil
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
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
Design outcomes
Primary
| 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. | done in Week 1, Week 7, Week 13 |
Secondary
| Measure | 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. | done in Week 1 and Week 13 |
Countries
Austria
Outcome results
None listed