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

Hyperhomocysteinemia Clinical Trial

— PERBIO-HC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264570
• Other study ID #: SW007
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: November 30, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhomocysteinemia

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (2)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.		6 months
Secondary	change in the level of very low density lipoproteins		6 months
Secondary	change of anxiety when using dietary supplements accessed by the Spielberg scale		6 months
Secondary	change of depression when using dietary supplements by the Becks scale		6 months
Secondary	occurrence of major cardiovascular events during follow-up		6 months