Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-29 @ 4:14 AM
Study NCT ID:
NCT06331195
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010840', 'term': 'Phytosterols'}], 'ancestors': [{'id': 'D013261', 'term': 'Sterols'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D064209', 'term': 'Phytochemicals'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-c', 'timeFrame': '120 days', 'description': 'Low-density lipoprotein cholesterol, in mg/dL'}, {'measure': 'Lp(a)', 'timeFrame': '120 days', 'description': 'Lipoprotein(a), in mg/dL'}], 'secondaryOutcomes': [{'measure': 'TC', 'timeFrame': '120 days', 'description': 'Total cholesterol, in mg/dL'}, {'measure': 'HDL-c', 'timeFrame': '120 days', 'description': 'High density lipoprotein cholesterol, in mg/dL'}, {'measure': 'TG', 'timeFrame': '120 days', 'description': 'Fasting triglycerides, in mg/dL'}, {'measure': 'VLDL', 'timeFrame': '120 days', 'description': 'Very low-density lipoprotein cholesterol, in mg/dL'}, {'measure': 'NHDL', 'timeFrame': '120 days', 'description': 'Non-HDL cholesterol, in mg/dL, calculated according to the mathematical formula: CT - HDL-c'}, {'measure': 'CI I', 'timeFrame': '120 days', 'description': 'Castelli Index I, in mg/dL, calculated according to the mathematical formula: CT/HDL-c'}, {'measure': 'CI II', 'timeFrame': '120 days', 'description': 'Castelli Index II, in mg/dL, calculated according to the mathematical formula: LDL-c/HDL-c'}, {'measure': 'TG/HDL-c', 'timeFrame': '120 days', 'description': 'TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c'}, {'measure': 'AI', 'timeFrame': '120 days', 'description': 'Atherogenic index, in mg/dL, calculated according to the mathematical formula: NHDL/HDL-c'}, {'measure': 'ox-LDL', 'timeFrame': '120 days', 'description': 'Oxidized LDL, in µg/mL'}, {'measure': 'APOAI', 'timeFrame': '120 days', 'description': 'Apolipoprotein A-I, in mg/dL'}, {'measure': 'APOB100', 'timeFrame': '120 days', 'description': 'Apolipoprotein B-100, in mg/dL'}, {'measure': 'AE', 'timeFrame': '120 days', 'description': 'Adverse events (mild, moderate and severe), registered as percentage per study group'}, {'measure': 'Adherence', 'timeFrame': '120 days', 'description': 'Adherence to treatment, evaluated by: attendance at consultations (at least 3 of the 4 planned study visits); diet quality; plasma concentrations of phytosterols and erythrocyte levels of EPA/DHA fatty acids (identified by the difference between the last and the first study visits); and counting the consumed products under investigation (consumption of at least 80% of the capsules provided to the participants, regardless of the allocation group).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Familial Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': '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; to identify the prevalence of subclinical atherosclerosis; to perform pharmacogenomic analysis; 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.\n\nPrimary 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.', 'detailedDescription': 'DICA-FH study is a superiority, factorial, and in parallel 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥16 years;\n* Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;\n* Using one of the following treatment regimens for ≥6 weeks according to age:\n\n\\>= 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.\n\n16 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).\n\nExclusion Criteria:\n\n* Having a "possible" FH result according to the Dutch MEDPED criteria;\n* TG ≥ 500mg/dL up to 6 months before screening for the study;\n* Diagnosis of hypercholesterolemia due to a secondary cause recorded in the medical record;\n* Food allergies (foods, dyes, preservatives);\n* Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);\n* HIV positive on treatment with detectable viral load or AIDS;\n* Chronic inflammatory or autoimmune diseases;\n* Known liver disease, chronic kidney disease on dialysis or pancreatitis (acute and chronic);\n* Cancer being treated or life expectancy \\< 6 months;\n* Episode of acute coronary syndrome in the last 60 days;\n* Chemical dependency/alcoholism;\n* Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;\n* Use of PCSK9 inhibitors (alirocumab, evolocumab, inclisiran);\n* Pregnancy or lactation;\n* Individuals who are unable to perform an anthropometric assessment, at the discretion of the investigator;\n* 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);\n* Use of dietary supplements that may interfere with the outcomes of interest (dietary fiber modules, n-3 PUFA, essential fatty acids);\n* Participation in other randomized clinical trials;\n* Refusal to participate in the study, due to failure to sign the Free and Informed Consent Form.'}, 'identificationModule': {'nctId': 'NCT06331195', 'acronym': 'DICA-FH', 'briefTitle': 'An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DICA-HF_MAIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'DICA-FH + placebo', 'description': '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.', 'interventionNames': ['Other: Placebo phytosterol', 'Other: Placebo krill oil']}, {'type': 'EXPERIMENTAL', 'label': 'DICA-FH + phytosterol', 'description': '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.', 'interventionNames': ['Other: Placebo krill oil', 'Dietary Supplement: Phytosterol']}, {'type': 'EXPERIMENTAL', 'label': 'DICA-HF + krill oil', 'description': '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.', 'interventionNames': ['Other: Placebo phytosterol', 'Dietary Supplement: Krill oil']}, {'type': 'EXPERIMENTAL', 'label': 'DICA-HF + phytosterol + krill oil', 'description': '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.', 'interventionNames': ['Dietary Supplement: Phytosterol', 'Dietary Supplement: Krill oil']}], 'interventions': [{'name': 'Placebo phytosterol', 'type': 'OTHER', 'description': 'Placebo of phytosterol, in the same quantity of the active phytosterol.', 'armGroupLabels': ['DICA-FH + placebo', 'DICA-HF + krill oil']}, {'name': 'Placebo krill oil', 'type': 'OTHER', 'description': 'Placebo of krill oil, in the same quantity of the active krill oil.', 'armGroupLabels': ['DICA-FH + phytosterol', 'DICA-FH + placebo']}, {'name': 'Phytosterol', 'type': 'DIETARY_SUPPLEMENT', 'description': '2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.', 'armGroupLabels': ['DICA-FH + phytosterol', 'DICA-HF + phytosterol + krill oil']}, {'name': 'Krill oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.', 'armGroupLabels': ['DICA-HF + krill oil', 'DICA-HF + phytosterol + krill oil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Aline Marcadenti, PhD', 'role': 'CONTACT', 'email': 'amarcaden@hcor.com.br', 'phone': '+551130536611'}], 'facility': 'Hcor', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Aline Marcadenti, PhD', 'role': 'CONTACT', 'email': 'amarcaden@hcor.com.br', 'phone': '+55 1130536611', 'phoneExt': '8203'}, {'name': 'Rachel Helena Machado, MSc', 'role': 'CONTACT', 'email': 'rhelena@ext.hcor.com.br', 'phone': '+55 1130536611', 'phoneExt': '8220'}], 'overallOfficials': [{'name': 'Aline Marcadenti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital do Coracao'}, {'name': 'Rachel Helena Machado, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital do Coracao'}, {'name': 'Erlon O Abreu-Silva, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital do Coracao'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}, {'name': 'National Institute of Cardiology, Laranjeiras, Brazil', 'class': 'OTHER_GOV'}, {'name': 'Instituto Dante Pazzanese de Cardiologia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}