Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT06331195
Eligibility Criteria:
Inclusion Criteria:
* Age ≥16 years;
* Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;
* Using one of the following treatment regimens for ≥6 weeks according to age:
\>= 20 years -\> simvastatin 40 mg; lovastatin 40 mg; pravastatin 80 mg; atorvastatin 20 mg; rosuvastatin 10 mg; pitavastatin 4 mg; fluvastatin 80 mg; atorvastatin 40- 80 mg; rosuvastatin 20 - 40 mg; atorvastatin 40 - 80 mg + ezetimibe 10mg; rosuvastatin 20 - 40 mg + ezetimibe 10mg; or simvastatin 40mg + ezetimibe 10mg.
16 to 19 years -\> simvastatin 10 - 40 mg; lovastatin 10 - 40 mg; pravastatin 10 - 40 mg; atorvastatin 10 - 40 mg; rosuvastatin 5 - 40 mg; cholestyramine 4 to 16 mg; ezetimibe 10mg (in combination with statin).
Exclusion Criteria:
* Having a "possible" FH result according to the Dutch MEDPED criteria;
* TG ≥ 500mg/dL up to 6 months before screening for the study;
* Diagnosis of hypercholesterolemia due to a secondary cause recorded in the medical record;
* Food allergies (foods, dyes, preservatives);
* Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
* HIV positive on treatment with detectable viral load or AIDS;
* Chronic inflammatory or autoimmune diseases;
* Known liver disease, chronic kidney disease on dialysis or pancreatitis (acute and chronic);
* Cancer being treated or life expectancy \< 6 months;
* Episode of acute coronary syndrome in the last 60 days;
* Chemical dependency/alcoholism;
* Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;
* Use of PCSK9 inhibitors (alirocumab, evolocumab, inclisiran);
* Pregnancy or lactation;
* Individuals who are unable to perform an anthropometric assessment, at the discretion of the investigator;
* Grade III/severe obesity (body mass index \[BMI\] ≥40kg/m² for adults or percentile \>99.9 or z-score \>+3 according to WHO/2006 growth curves for BMI/Age indicator for adolescents);
* Use of dietary supplements that may interfere with the outcomes of interest (dietary fiber modules, n-3 PUFA, essential fatty acids);
* Participation in other randomized clinical trials;
* Refusal to participate in the study, due to failure to sign the Free and Informed Consent Form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT06331195
Study Brief:
Protocol Section:
NCT06331195