Personalized approach to lowering high blood homocysteine levels
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.
Run by S.lab (Soloways) · NCT06264570 · Data updated 2026-11-12
This study is testing a personalized treatment plan to see if it can lower high blood homocysteine levels in people at risk for heart disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 111 (estimated) |
| Sponsor | S.lab (Soloways) Academic / other |
| Locations | 1 site (Novosibirsk, Novosibisk Region) |
| Status | Recruiting |
| Started | October 23, 2023 |
| Main results expected | December 15, 2025 |
| Study ends | October 30, 2026 |
| Registry record updated | June 8, 2025 |
| Trial ID | NCT06264570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with elevated homocysteine levels above 15 µmol/L and elevated LDL levels.
✕Probably not a fit
Patients with severe concomitant diseases or those currently taking medications that affect homocysteine levels may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness and safety of a genetically-determined personalized method for prescribing bioactive substances to patients with elevated blood homocysteine levels, a known risk factor for cardiovascular diseases. The study is designed as a single-center, prospective, double-blind, placebo-controlled trial, with a 6-month observation period involving visits at 1, 3, and 6 months. Participants will receive either active bioactive substances or placebos, and the primary goal is to reduce plasma homocysteine levels to below 15 µmol/L, while secondary goals include lowering LDL levels and assessing mental health outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cardiovascular risks associated with high homocysteine levels in patients.
How similar studies have gone: While the approach is innovative, similar studies targeting hyperhomocysteinemia with personalized interventions have shown promise, but this specific methodology is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Center of New Medical Technologies
Novosibirsk, Novosibisk Region, Russia Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.