An interventional study of B-TMG supplementation and B-SAM supplementation in Hyperhomocysteinemia, sponsored by S.LAB (SOLOWAYS). Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by S.LAB (SOLOWAYS) · Not applicable, Interventional, and Treatment
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.
34 studies on the registry are indexed under Hyperhomocysteinemia; 4 are open to participants now.
This study's planned enrollment of 111 is above the median of 84 across 21 interventional studies indexed under Hyperhomocysteinemia.
Browse Hyperhomocysteinemia studies →S.LAB (SOLOWAYS) is the lead sponsor of 29 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Subjects with normal COMT gene and MTHFR gene polymorphism
Dietary Supplement: B-TMG supplementation
Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene
Dietary Supplement: B-SAM supplementation
Subjects with normal COMT gene and MTHFR gene polymorph polymorphism ysm
Other: B-TMG placebo
Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene
Other: B-SAM placebo
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 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 for subjects with normal COMT gene and MTHFR gene polymorphism
B-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene
Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.
Time frame: 6 months
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
Started Oct 2023 (actual). Primary completion is estimated for Dec 2025, 25 months after the start.
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S.LAB (SOLOWAYS)