Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.

Not Applicable

Completed

• Conditions: Hyperhomocysteinemia; Hyperlipoproteinemias
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin B

• Registration Number: NCT06163443
• Lead Sponsor: S.LAB (SOLOWAYS)

Brief Summary

This randomized, double-blind, placebo-controlled trial will evaluate the impact of methylfolate, pyridoxal-5'-phosphate (P5P), and methylcobalamin supplementation on homocysteine and LDL-C levels in individuals with low to medium cardiac risk and MTHFR, MTR, and MTRR gene polymorphisms. The study aims to explore the efficacy of these vitamins in reducing homocysteine levels, a critical risk factor for cardiovascular disease (CVD), while also monitoring LDL-C levels. The findings will offer valuable insights into personalized CVD prevention and management, emphasizing the significance of genetic factors in nutritional therapy.

Detailed Description

Design: Participants with specific genetic polymorphisms and homocysteine levels above 15 µmol/L, without a history of severe CVD or other exclusion criteria, will be enrolled and randomized into two groups: one receiving methylfolate, P5P, and methylcobalamin, and the other a placebo. The study, adhering to ethical standards and informed consent, will involve 54 patients divided equally between the treatment and placebo groups. The primary endpoint will be the percent change in homocysteine levels over six months, with secondary endpoints including changes in LDL-C and other lipid profile components.

Intervention: Participants will receive either the active treatment (L-methylfolate, P5P, and Methylcobalamin) or a placebo, with both groups taking two capsules daily for 180 days. Fasting measurements of lipid profiles and homocysteine levels will be conducted at the start, midpoint, and end of the study.

Study Timeline

• Study Start: 2022-03-02
• Primary Completion: 2023-02-13
• Study Completion: 2023-05-01
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Age between 40 and 75.
• Homocysteine levels greater than 15 µmol/L and LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.
• Presence of at least one minor allele in any of the following genetic polymorphisms: rs1801133 (MTHFR C677T), rs1801131 (MTHFR A1298C), rs1805087 (MTR A2756G), and rs1801394 (MTRR A66G).

Exclusion Criteria

• Personal history of cardiovascular disease or high risk (≥ 20%).
• Triglycerides (TG) ≥ 400 mg/dL.
• Obesity (Body Mass Index > 32 kg/m^2).
• Assumption of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months.
• Use of medications or supplements known to affect homocysteine levels, such as B-vitamins and certain antihypertensives, within the last three months.
• Diabetes mellitus.
• Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Patients with polymorphisms in the MTHFR, MTR, and MTRR will take placebo capsules will be identical in appearance, matched for color coating, shape, and size - 2 capsules/day..
Vitamin B group	Vitamin B	Patients with polymorphisms in the MTHFR, MTR, and MTRR will take methylfolate, P5P, and methylcobalamin genes 2 capsules/day.

Primary Outcome Measures

Name	Time	Method
Homocysteine levels	180 days	The primary endpoint is the percent change in homocysteine levels from baseline to 6 months of observation, comparing a combined treatment regimen of methylfolate, P5P, and methylcobalamin in MTHFR, MTR, and MTRR polymorphysm.

Secondary Outcome Measures

Name	Time	Method
Change in HDL-C Levels	180 days	Percent change in High-Density Lipoprotein Cholesterol (HDL-C) levels.
Change in LDL-C Levels	180 days	Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) levels.
Change in Total Cholesterol	180 days	Percent change in total cholesterol levels in the study participants.
Change in Serum Triglycerides	180 days	Percent change in serum triglycerides.
Change in hsCRP Levels	180 days	Percent change in high-sensitivity C-Reactive Protein (hsCRP) levels.

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibirsk Region, Russian Federation