Early Detection of Familial Hypercholesterolemia in Children

Condition(s) studied

Investigational drug(s) / intervention(s)

lifestyle assessment: A semi-quantitative assessment of the consumption of different food groups will be carried out using a frequency questionnaire validated by the Spanish population27. This questionnaire consists of 137 food items and will be obtained by the dietitian of our Unit (see annex). The child population and/or their parents will be instructed on how to fill the data in the food diary for a period of 3 days, in order to be able to analyse the nutritional composition of the intake and the effect on the lipid profile. The first food register, will be obtained at the collection visit before starting any type of treatment. Another food diary will be included after one year. Physical activity will be collected from the Minnesota Test and we will ask about the consumption of tobacco.

Study summary

Heterozigous FH is an underdiagnosed disease in the paediatric population. Its early detection, would allow us to initiate lifestyle therapeutical changes and early pharmacological therapy if necessary. This is a key fact to reduce atherosclerosis progression and cardiovascular risk in adulthood. Moreover, it will allow, detecting the first and second degree affected relatives.

Eligibility

Primary outcome measure(s)

• Number the children detected of FH — From date of randomization until the date of first documented progression, assessed up to 10 years.
  The main result of the study is to increase the number of children affected by FH, as well as to detect their families.

Trial sites (2)

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