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

RecruitingNAAges 18 Years - 80 YearsAllS.LAB (SOLOWAYS)
NCT06264570 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 endp

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📋 Eligibility rules (as published)
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.
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What it tests

  • B-TMG supplementation
  • B-SAM supplementation
  • B-TMG placebo
  • B-SAM placebo
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Where

1 site
Center of New Medical Technologies
Novosibirsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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