Placebo phytosterol: Placebo of phytosterol, in the same quantity of the active phytosterol.
Placebo krill oil: Placebo of krill oil, in the same quantity of the active krill oil.
Phytosterol: 2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.
Krill oil: 2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.
The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil. Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up.
| Facility | City | Region | Status |
|---|---|---|---|
| Hcor | São Paulo | São Paulo | |
| OCARA | Belém | Brazil | |
| Centro Oncológico de Roraima | Boa Vista | Brazil | |
| Instituto de Cardiologia e Transplantes do DF | Brasília | Brazil | |
| Universidade do Mato Grosso do Sul | Campo Grande | Brazil | |
| Universidade Federal do Mato Grosso | Cuiabá | Brazil | |
| Hospital Oto Aldeota | Fortaleza | Brazil | |
| Universidade Federal de Goiás | Goiânia | Brazil | |
| Universidade Federal do Amapá | Macapá | Brazil | |
| Centro de Pesquisas Clínicas Dr. Marco Mota | Maceió | Brazil | |
| Universidade Federal do Amazonas | Manaus | Brazil | |
| Universidade Estadual de Maringá | Maringá | Brazil | |
| Santa Casa de Montes Claros | Montes Claros | Brazil | |
| Centro de Estudos e Pesquisas em Moléstias Infecciosas | Natal | Brazil | |
| Universidade Federal do Tocantins | Palmas | Brazil | |
| Universidade Federal do Vale do São Francisco | Petrolina | Brazil | |
| Instituto de Pesquisa e Ensino em Saúde | Porto Velho | Brazil | |
| Centro de Pesquisa Silvestre Santé | Rio Branco | Brazil | |
| Instituto Nacional de Cardiologia | Rio de Janeiro | Brazil | |
| Hospital Ana Nery | Salvador | Brazil | |
| InCor | São Paulo | Brazil | |
| Instituto Dante Pazzanese de Cardiologia | São Paulo | Brazil | |
| Universidade Federal de São Paulo | São Paulo | Brazil | |
| Centro de Pesquisa Cardiolima | Teresina | Brazil |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06331195 on ClinicalTrials.gov ↗ ← All trials in Brazil