An interventional study of Vitamin B and Placebo in Hyperhomocysteinemia and Hyperlipoproteinemias, sponsored by S.LAB (SOLOWAYS). Completed at 1 site in Russian Federation. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by S.LAB (SOLOWAYS) · Not applicable, Interventional, and Treatment
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.
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.
34 studies on the registry are indexed under Hyperhomocysteinemia; 4 are open to participants now.
This study's enrollment of 54 is below 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with polymorphisms in the MTHFR, MTR, and MTRR will take methylfolate, P5P, and methylcobalamin genes 2 capsules/day.
Dietary Supplement: Vitamin B
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 L-methylfolate (1 mg), P5P (pyridoxal-5-phosphate, 50 mg), and Methylcobalamin (500 mcg) prescription
MTHFR, MTR, and MTRR polymorphysm based placebo prescription
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.
Time frame: 180 days
Change in LDL-C Levels
Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) levels.
Time frame: 180 days
Change in HDL-C Levels
Percent change in High-Density Lipoprotein Cholesterol (HDL-C) levels.
Time frame: 180 days
Change in Total Cholesterol
Percent change in total cholesterol levels in the study participants.
Time frame: 180 days
Change in Serum Triglycerides
Percent change in serum triglycerides.
Time frame: 180 days
Change in hsCRP Levels
Percent change in high-sensitivity C-Reactive Protein (hsCRP) levels.
Time frame: 180 days
Plan to share: Undecided
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin B Complex
S.LAB (SOLOWAYS)