nctId: NCT06264570 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 overallStatus: RECRUITING date: 2023-10-23 date: 2024-05-15 date: 2024-11-30 date: 2024-02-20 date: 2024-03-13 name: S.LAB (SOLOWAYS) class: OTHER name: Center of New Medical Technologies 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. conditions: Hyperhomocysteinemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 111 type: ESTIMATED name: B-TMG supplementation name: B-SAM supplementation name: B-TMG placebo name: B-SAM placebo measure: Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l. measure: change in the level of very low density lipoproteins measure: change of anxiety when using dietary supplements accessed by the Spielberg scale measure: change of depression when using dietary supplements by the Becks scale measure: occurrence of major cardiovascular events during follow-up sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of New Medical Technologies status: RECRUITING city: Novosibirsk state: Novosibisk Region zip: 630090 country: Russian Federation name: Andrei AV Ponomarenko, MD role: CONTACT phone: +79628316017 email: dayshadoff@gmail.com name: Elena EI Krykova role: CONTACT phone: +79133825952 email: krukova_ei@cnmt.ru name: Eugene EA Pokushalov, PhD role: PRINCIPAL_INVESTIGATOR name: Andrei AV Ponomarenko, MD role: SUB_INVESTIGATOR lat: 55.0415 lon: 82.9346 hasResults: False