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RECRUITING
NCT06861062
NA

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Sponsor: Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, placebo-controlled trial involving 2,500 individuals aged 40-79 with type 2 diabetes (T2D). The trial includes a 2-year intervention period followed by a 3-year post-intervention follow-up. The primary objective is to investigate (a) the effect of daily supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) on glycemic control in patients with T2D and (b) whether daily supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) reduces the predicted 10 year risk of atherosclerotic cardiovascular disease (ASCVD) in patients with T2D. The secondary objectives include evaluating the effects of vitamin D3 or yeast β-glucan supplementation on cardiometabolic risk factors, inflammatory markers, and liver and kidney function indicators, and assessing whether such supplementation reduces the risk of cardiovascular disease, microvascular complications and mortality over the 3-year post-intervention period.

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

Key Details

Gender

All

Age Range

40 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2025-04-08

Completion Date

2032-12-31

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Vitamin D3

Vitamin D3(cholecalciferol),1600 IU per day.

DIETARY_SUPPLEMENT

yeast β-glucan

yeast β-glucan, 600mg per day.

DIETARY_SUPPLEMENT

Vitamin D placebo

Vitamin D placebo

DIETARY_SUPPLEMENT

yeast β-glucan placebo

yeast β-glucan placebo

Locations (5)

Guangxi Medical College

Nanning, Guangxi, China

Kailuan General Hospital

Tangshan, Hebei, China

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, China

Huazhong University of Science and Technology

Wuhan, Hubei, China

Sichuan University

Chengdu, Sichuan, China