Effects of an Adapted Brazilian Cardioprotective Diet Supplemented or Not With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: the DICA-FH Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 36
- 主要终点
- LDL-c
研究概览
简要总结
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.
详细描述
DICA-FH study is a superiority, factorial, and in parallel multicenter randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 20 center sites in different Brazilian geographic regions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
DICA-HF + phytosterol + krill oil
Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.
干预措施: Phytosterol (Dietary Supplement)
DICA-HF + phytosterol + krill oil
Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.
干预措施: Krill oil (Dietary Supplement)
DICA-HF + krill oil
Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of krill oil and placebo of phytosterol during 120 days.
干预措施: Krill oil (Dietary Supplement)
DICA-FH + placebo
Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus placebo of both phytosterol and krill oil during 120 days.
干预措施: Placebo phytosterol (Other)
DICA-FH + placebo
Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus placebo of both phytosterol and krill oil during 120 days.
干预措施: Placebo krill oil (Other)
DICA-FH + phytosterol
Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of phytosterol and placebo of the krill oil during 120 days.
干预措施: Placebo krill oil (Other)
DICA-FH + phytosterol
Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of phytosterol and placebo of the krill oil during 120 days.
干预措施: Phytosterol (Dietary Supplement)
DICA-HF + krill oil
Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of krill oil and placebo of phytosterol during 120 days.
干预措施: Placebo phytosterol (Other)
结局指标
主要结局
LDL-c
时间窗: 120 days
Low-density lipoprotein cholesterol, in mg/dL
Lp(a)
时间窗: 120 days
Lipoprotein(a), in mg/dL
次要结局
- TC(120 days)
- TG(120 days)
- VLDL(120 days)
- CI I(120 days)
- APOAI(120 days)
- APOB100(120 days)
- Adherence(120 days)
- HDL-c(120 days)
- NHDL(120 days)
- ox-LDL(120 days)
- CI II(120 days)
- TG/HDL-c(120 days)
- AI(120 days)
- AE(120 days)