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Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery

NCT07348328 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-01-16

No results posted yet for this study

Summary

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.

Conditions

  • Cardiovascular Surgical Procedures
  • Major Adverse Cardiovascular Events (MACE)

Interventions

DRUG

Compound Vitamin B tablet

perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery

DRUG

Control

perioperative supplementation with placebo, once daily from 3 days before surgery to 6 months after surgery

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • Shanghai East Hospital

    collaborator OTHER

  • Nanjing Medical University

    lead OTHER

Principal Investigators

  • Guo-liang Fan · Shanghai East Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07348328 on ClinicalTrials.gov