Status:
COMPLETED
Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.
Lead Sponsor:
S.LAB (SOLOWAYS)
Collaborating Sponsors:
Triangel Scientific
Center of New Medical Technologies
Conditions:
Hyperhomocysteinemia
Hyperlipoproteinemias
Eligibility:
All Genders
40-75 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06163443
Start Date
March 2 2022
End Date
May 1 2023
Last Update
March 27 2025
Active Locations (1)
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1
Center of New Medical Technologies
Novosibirsk, Novosibirsk Oblast, Russia, 630090