Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B-TMG supplementation, B-SAM supplementation, B-TMG placebo, B-SAM placebo.
- Who it may be relevant to
- Registry conditions: Hyperhomocysteinemia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels, Prospective,Double-blind Randomised Trial.
Overview
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.
Interventions
- Dietary supplement 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 - 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 - Other B-TMG placebo
B-TMG placebo for subjects with normal COMT gene and MTHFR gene polymorphism - Other B-SAM placebo
B-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene
Primary outcome measures
- Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l. [Time frame: 6 months]
Secondary outcome measures (4)
- change in the level of very low density lipoproteins [Time frame: 6 months]
- change of anxiety when using dietary supplements accessed by the Spielberg scale [Time frame: 6 months]
- change of depression when using dietary supplements by the Becks scale [Time frame: 6 months]
- occurrence of major cardiovascular events during follow-up [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Center of New Medical Technologies — Novosibirsk
Identifiers
NCT: NCT06264570 · SW007