NCT06163443 (VITAGEN-H) is a NA clinical trial of Vitamin B in Hyperhomocysteinemia, sponsored by S.LAB (SOLOWAYS).

Who is sponsoring NCT06163443?

NCT06163443 is sponsored by S.LAB (SOLOWAYS).

What drugs are being tested in NCT06163443?

Interventions in NCT06163443: Vitamin B, Placebo.

What condition does NCT06163443 study?

NCT06163443 studies Hyperhomocysteinemia, Hyperlipoproteinemias.

Is NCT06163443 still recruiting?

NCT06163443 is currently completed. Last updated 27 March 2025.

Last reviewed 2025-03-27 · How we verify

NCT06163443: VITAGEN-H

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 27 March 2025

What this trial tests

NA trial testing Vitamin B in Hyperhomocysteinemia in 54 participants. Completed in 1 May 2023.

Timeline

2 March 2022

Primary endpoint
13 February 2023

1 May 2023

Quick facts

Lead sponsor	S.LAB (SOLOWAYS)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	54
Start date	2 March 2022
Primary completion	13 February 2023
Estimated completion	1 May 2023
Sites	1 location across Russia

Drugs / interventions tested

Vitamin B
Placebo

Conditions studied

Hyperhomocysteinemia — all drugs for Hyperhomocysteinemia →
Hyperlipoproteinemias — all drugs for Hyperlipoproteinemias →

Sponsor

S.LAB (SOLOWAYS) — full company profile →

Who can join

Adults 40 to 75, any sex, with Hyperhomocysteinemia or Hyperlipoproteinemias. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of Methylfolate, Pyridoxal-5'-Phosphate, and Methylcobalamin (Soloways<sup>TM</sup>) Supplementation on Homocysteine and Low-Density Lipoprotein Cholesterol Levels in Patients with Methylenetetrahydrofolate Reductase, Methionine Synthase, and Methionine Synthase Reductase
Pokushalov E, Ponomarenko A, Bayramova S, Garcia C, et al · · 2024 · cited 7× · PMID 38892484 · DOI 10.3390/nu16111550

Verify or expand the search:

Other trials of Vitamin B

Trials testing the same drug.

NCT05663164 — Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS) · NA · completed

Other recruiting trials for Hyperhomocysteinemia

Currently open trials in the same condition.

NCT06264570 — Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients W · NA · recruiting

Other S.LAB (SOLOWAYS) trials

Trials by the same sponsor.

NCT06877377 — Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patien · NA · not yet recruiting
NCT06877364 — Safety, Tolerability and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases · Phase 1, PHASE2 · completed
NCT06434077 — Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Br · Phase 3 · not yet recruiting
NCT06264544 — Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Sub · NA · not yet recruiting
NCT06269406 — A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06163443 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by S.LAB (SOLOWAYS)
Last refreshed: 27 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06163443.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing