NCT06264570 Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.
| NCT ID | NCT06264570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | S.LAB (SOLOWAYS) |
| Condition | Hyperhomocysteinemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 111 participants |
| Start Date | 2023-10-23 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 111 participants in total. It began in 2023-10-23 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Increased homocysteine level above 15 µmol/l; * Increased LDL level \>=1.4 mmol/l.; * Absence of taking medications or any other products that may affect homocysteine levels in the blood for at least 1 month before enrollment in the study; Exclusion Criteria: * Individual intolerance to the components of the substance; * Pregnancy or breastfeeding; * Severe concomitant disease requiring constant monitoring (estimated survival less than 1 year); * Taking dietary supplements or medications containing one of the components: dietary supplements for at least 3 months before inclusion in the study.
Frequently Asked Questions
Who can join the NCT06264570 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hyperhomocysteinemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06264570 currently recruiting?
Yes, NCT06264570 is actively recruiting participants. Visit ClinicalTrials.gov or contact S.LAB (SOLOWAYS) to inquire about joining.
Where is the NCT06264570 trial being conducted?
This trial is being conducted at Novosibirsk, Russia.
Who is sponsoring the NCT06264570 clinical trial?
NCT06264570 is sponsored by S.LAB (SOLOWAYS). The trial plans to enroll 111 participants.