Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery

Starting soon · Not applicable · Has a placebo group

Conditions studied: Cardiovascular Surgical Procedures, Major Adverse Cardiovascular Events (MACE)

In brief

This study is a multicenter, randomized controlled, double-blind, placebo-controlled parallel trial designed to evaluate the effect of perioperative supplementation with Compound Vitamin B on patients undergoing cardiovascular surgery. A total of 1,000 patients aged 18-80 years who are scheduled to receive cardiovascular surgeries such as coronary artery bypass grafting (CABG) and valve replacement will be enrolled. They will be randomly assigned at a 1:1 ratio to either the experimental group (perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery) or the control group (oral placebo), with both groups receiving standardized perioperative treatment.

Key facts

Study ID

NCT07348328

Run by

Nanjing Medical University

People needed

1000

Starts

2026-02-01

Expected to finish

2027-12-31

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18-80 years, regardless of gender;
• Scheduled to receive cardiovascular surgery at the research center, including coronary artery bypass grafting (CABG), cardiac valve replacement/repair, and great vessel surgery;
• Preoperative assessment indicates that the patient is expected to complete the 6-month postoperative follow-up;
• The patient or their authorized agent signs a written informed consent form.

You may not qualify if…

• Regular supplementation with Compound Vitamin B (daily dose ≥ 1.5 times the recommended dietary allowance) or separate supplementation with folic acid, vitamin B6, or B12 within 3 months before surgery;
• Severe hepatic or renal insufficiency (liver function: ALT/AST > 3 times the upper limit of normal, or total bilirubin > 2 times the upper limit of normal; renal function: serum creatinine > 265 μmol/L, or requiring long-term dialysis treatment);
• Malignant tumors, severe hematological diseases (e.g., megaloblastic anemia, aplastic anemia), severe malnutrition (albumin < 25 g/L);
• History of allergy to Compound Vitamin B preparations or placebo components; Pregnant women, lactating women, or those planning to become pregnant during the study period;
• Currently participating in other interventional clinical trials;
• Moderate to severe cognitive impairment without a fixed caregiver, unable to cooperate with treatment and follow-up;
• Preoperatively diagnosed with severe infection, septicemia, or septic shock.

Where it is running

• Shanghai East Hospital Tongji University — Shanghai, DR, China
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.