protocolSection identificationModule nctId: NCT06264570, orgStudyIdInfo id: SW007, briefTitle: Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels., acronym: PERBIO-HC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: S.LAB (SOLOWAYS), class: OTHER, collaborators name: Center of New Medical Technologies, descriptionModule briefSummary: The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (\<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (\>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results., conditionsModule conditions: Hyperhomocysteinemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 111, type: ESTIMATED, armsInterventionsModule interventions name: B-TMG supplementation, interventions name: B-SAM supplementation, interventions name: B-TMG placebo, interventions name: B-SAM placebo, outcomesModule primaryOutcomes measure: Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l., secondaryOutcomes measure: change in the level of very low density lipoproteins, secondaryOutcomes measure: change of anxiety when using dietary supplements accessed by the Spielberg scale, secondaryOutcomes measure: change of depression when using dietary supplements by the Becks scale, secondaryOutcomes measure: occurrence of major cardiovascular events during follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of New Medical Technologies, status: RECRUITING, city: Novosibirsk, state: Novosibisk Region, zip: 630090, country: Russian Federation, contacts name: Andrei AV Ponomarenko, MD, role: CONTACT, phone: +79628316017, email: dayshadoff@gmail.com, contacts name: Elena EI Krykova, role: CONTACT, phone: +79133825952, email: krukova_ei@cnmt.ru, contacts name: Eugene EA Pokushalov, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrei AV Ponomarenko, MD, role: SUB_INVESTIGATOR, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False