Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163443
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2023-11-22
Brief Title:
Evaluating the Impact of B Vitamin Supplementation Soloways on Homocysteine and LDL-C Levels in Patients With MTHFR MTR and MTRR Polymorphisms
Sponsor:
SLAB SOLOWAYS
Organization:
SLAB SOLOWAYS
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITAGEN-H
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 µmolL 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None