NCT05861648

Folic Acid Supplementation in Calcific Aortic Valve Disease

Effect of Folic Acid Supplementation in Patient's Calcific Aortic Valve Disease With Mild Aortic Valve Stenosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of folic acid compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.

Detailed description

Folic acid is involved in important physiological activities in the body such as DNA synthesis, cell division and growth and development. Recent studies have shown that folic acid may also have a positive effect on cardiovascular system health. Aortic valve calcification is a cardiovascular disease whose incidence increases progressively with age. Early studies suggest that folic acid may slow the progression of aortic valve calcification by inhibiting cell calcification and promoting calcium deposition. Participants were randomized into two groups: one group was given oral folic acid treatment and the other group was given placebo control. Patients in both groups were observed for aortic valve calcification during the follow-up period, and changes in aortic valve thickness, degree of calcification, and flow were recorded by cardiac ultrasonography, while the incidence of cardiovascular events and adverse effects were assessed.

Conditions

• Calcification of Aortic Valve
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DRUG	Folic Acid Oral Tablet	Dietary Supplement: Folic acid 2.5mg/day
DIETARY_SUPPLEMENT	Placebo	Dietary Supplement: Placebo

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-07-01
• Completion: 2028-07-01
• First posted: 2023-05-17
• Last updated: 2023-05-17

Regulatory

• FDA-regulated drug study