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

Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms: A Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipoproteinemias; Hyperhomocysteinemia
• Intervention / Treatment: Dietary supplement: Vitamin B; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk Region
    • Novosibirsk, Novosibirsk Region, Russian Federation, 630090
      • Center of New Medical Technologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin B group; Patients with polymorphisms in the MTHFR, MTR, and MTRR will take methylfolate, P5P, and methylcobalamin genes 2 capsules/day.	Dietary supplement: Vitamin B; MTHFR, MTR, and MTRR polymorphysm based L-methylfolate (1 mg), P5P (pyridoxal-5-phosphate, 50 mg), and Methylcobalamin (500 mcg) prescription
Placebo Comparator: Placebo group; 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..	Dietary supplement: Placebo; MTHFR, MTR, and MTRR polymorphysm based placebo prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homocysteine levels	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.	180 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center of New Medical Technologies; Triangel Scientific

Publications and helpful links

General Publications

• Pokushalov E, Ponomarenko A, Bayramova S, Garcia C, Pak I, Shrainer E, Ermolaeva M, Kudlay D, Johnson M, Miller R. Effect of Methylfolate, Pyridoxal-5'-Phosphate, and Methylcobalamin (SolowaysTM) Supplementation on Homocysteine and Low-Density Lipoprotein Cholesterol Levels in Patients with Methylenetetrahydrofolate Reductase, Methionine Synthase, and Methionine Synthase Reductase Polymorphisms: A Randomized Controlled Trial. Nutrients. 2024 May 21;16(11):1550. doi: 10.3390/nu16111550.

Helpful Links

• 10.3390/nu16111550

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Cholesterol; LDL-C; Cardiovascular Risk; Homocysteine; Methylcobalamin; Low-Density Lipoprotein; Methylfolate; Genetic Polymorphisms (MTHFR, MTR, MTRR)
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Malabsorption Syndromes; Dyslipidemias; Lipid Metabolism Disorders; Amino Acid Metabolism, Inborn Errors; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Hyperlipidemias; Hyperlipoproteinemias; Hyperhomocysteinemia; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex
• Other Study ID Numbers: SW002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No