Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.

Not Applicable

Recruiting

• Conditions: Hyperhomocysteinemia

• Registration Number: NCT06264570
• Lead Sponsor: S.LAB (SOLOWAYS)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-23
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-08
• Primary Completion: 2025-12-15
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.	6 months

Secondary Outcome Measures

Name	Time	Method
change in the level of very low density lipoproteins	6 months
occurrence of major cardiovascular events during follow-up	6 months
change of depression when using dietary supplements by the Becks scale	6 months
change of anxiety when using dietary supplements accessed by the Spielberg scale	6 months

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibisk Region, Russian Federation