Early Detection of Familial Hypercholesterolemia in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorInstitut Investigacio Sanitaria Pere Virgili

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Children between 2 and 18 years of age.

LDL-C level above 135 mg/dL

Previously, the pediatrician will have discarded secondary causes (hypercholesterolaemia such as hypothyroidism, nephrotic syndrome, diabetes, renal insufficiency).

Disqualifiers

The child population under 2 and over the age of 18 and children.

Children with high cholesterol but by secondary causes.

Trial population

Children between 2 and 18 years of age who have a LDL-C level above 135 mg/dL.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • lifestyle assessment

    Other intervention

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Familial hypercholesterolaemia children1 intervention
Group B: Unaffected children1 intervention

Trial outcomes

Primary outcomes

1

Number the children detected of FH

The main result of the study is to increase the number of children affected by FH, as well as to detect their families.

Time frame
From date of randomization until the date of first documented progression, assessed up to 10 years.

Secondary outcomes

1

LDL-cholesterol level (mg/dl) at entry and at follow-up

LDL-cholesterol measurement at enrolment and after follow-up.

Time frame
every year, up to 10 years
2

Healthy habits of population

Food frequency questionnarie will be carried out by a registered dietician-nutritionist every year to see if children improve their diet

Time frame
every year, up to 10 years

Other outcomes

Sponsors and contacts

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