Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Cardiovascular Disease in Patients With Type 2 Diabetes: A Randomized Double-Blind Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a randomized, double-blind, placebo-controlled trial involving 8,000 individuals aged 40-79 with type 2 diabetes. The trial includes a 2-year intervention period followed by 3 years of follow-up. The primary objective is to investigate whether daily dietary supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) reduces the risk of major cardiovascular diseases, including myocardial infarction, stroke, treated or hospitalized heart failure, and cardiovascular deaths. The secondary objectives include evaluating the effects of vitamin D3 or yeast β-glucan supplementation on all-cause mortality, microvascular disease, cognitive function, and other outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 79
Healthy Volunteers: f
View:

• Type 2 diabetes mellitus diagnosed by a physician based on the diagnostic criteria outlined in the Guideline for the Prevention and Treatment of Diabetes Mellitus in China (2024 Edition);

• Men or women aged 40-79 years;

• Convenient access to the study centers and permanent residence in the vicinity for the next five years;

• Voluntary participation and signed written informed consent.

Locations
Other Locations
China
Sichuan University
RECRUITING
Chengdu
Guangxi Medical College
RECRUITING
Nanning
Sinopharm Dongfeng General Hospital
RECRUITING
Shiyan
Kailuan General Hospital
RECRUITING
Tangshan
Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Gang Liu, PHD
liugang026@hust.edu.cn
86-15926238366
Backup
Tianyu Guo
D202482059@hust.edu.cn
86-18210047875
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 8000
Treatments
Active_comparator: Vitamin D + yeast β-glucan
Active_comparator: Vitamin D + yeast β-glucan placebo
Active_comparator: yeast β-glucan +Vitamin D placebo
Placebo_comparator: Vitamin D placebo + yeast β-glucan placebo
Sponsors
Leads: Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov