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

NCT ID: NCT06264570

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2026-10-30

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.

Conditions

Hyperhomocysteinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

B-TMG experimental group

Subjects with normal COMT gene and MTHFR gene polymorphism

Group Type: EXPERIMENTAL

B-TMG supplementation

Intervention Type: DIETARY_SUPPLEMENT

B-TMG supplement (B2 riboflavin, B6 pyroxidine, B9 methylfolate, B12 methylcobalamine, S-adenosylmethionine, Trimethylglycerol (TMG), zinc sulfate) for subjects with normal COMT gene and MTHFR gene polymorphism

B-SAM experimental group

Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

Group Type: EXPERIMENTAL

B-SAM supplementation

Intervention Type: DIETARY_SUPPLEMENT

B-SAM supplement (B2 riboflavin, B6 pyroxidine, B9 folic acid, B12 adenosylcobalamin, magnesium, S-adenosylmethionine) for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

B-TMG placebo group

Subjects with normal COMT gene and MTHFR gene polymorph polymorphism ysm

Group Type: PLACEBO_COMPARATOR

B-TMG placebo

Intervention Type: OTHER

B-TMG placebo for subjects with normal COMT gene and MTHFR gene polymorphism

B-SAM placebo group

Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

Group Type: PLACEBO_COMPARATOR

B-SAM placebo

Intervention Type: OTHER

B-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

Interventions

B-TMG supplementation

B-TMG supplement (B2 riboflavin, B6 pyroxidine, B9 methylfolate, B12 methylcobalamine, S-adenosylmethionine, Trimethylglycerol (TMG), zinc sulfate) for subjects with normal COMT gene and MTHFR gene polymorphism

Intervention Type: DIETARY_SUPPLEMENT

B-SAM supplementation

B-SAM supplement (B2 riboflavin, B6 pyroxidine, B9 folic acid, B12 adenosylcobalamin, magnesium, S-adenosylmethionine) for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

Intervention Type: DIETARY_SUPPLEMENT

B-TMG placebo

B-TMG placebo for subjects with normal COMT gene and MTHFR gene polymorphism

Intervention Type: OTHER

B-SAM placebo

B-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center of New Medical Technologies

OTHER

Sponsor Role: collaborator

S.LAB (SOLOWAYS)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia

Site Status: RECRUITING

Countries

Russia

Facility Contacts

Andrei AV Ponomarenko, MD

Role: primary

dayshadoff@gmail.com

+79628316017

Elena EI Krykova

Role: backup

krukova_ei@cnmt.ru

+79133825952

Other Identifiers

SW007

Identifier Type: -

Identifier Source: org_study_id