Daily vitamin D3 and yeast beta-glucan for blood sugar control and heart disease risk in people with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled 2×2 factorial trial will enroll about 2,500 adults aged 40–79 with type 2 diabetes and randomly assign them to daily vitamin D3, yeast β-glucan, both, or double placebo for two years. Participants will take four capsules daily and complete questionnaires, physical exams, and blood, urine, and feces sample collections at study centers. Primary outcomes are changes in glycemic control and predicted 10-year ASCVD risk, while secondary outcomes include cardiometabolic risk factors, inflammatory markers, liver and kidney function, and clinical cardiovascular and microvascular events during a three-year post-intervention follow-up. The multicenter design in China allows long-term monitoring to detect both metabolic and clinical effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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);
2. Men or women aged 40-79 years;
3. Convenient access to the study centers and permanent residence in the vicinity for the next five years;
4. Voluntary participation and signed written informed consent.

Exclusion Criteria:

1. History of clinical cardiovascular disease (including myocardial infarction, treatment or hospitalization for heart failure, stroke, and coronary revascularization) within the past 6 months;
2. History of severe diabetic microvascular complications (diabetic nephropathy with an estimated glomerular filtration rate (eGFR) \< 30 mL/(min·1.73m²), proliferative diabetic retinopathy, confirmed diabetic peripheral neuropathy with abnormal nerve conduction studies or small fiber neuropathy testing);
3. History of cancer, excluding non-melanoma skin cancer or cancers with a favorable prognosis;
4. History of kidney stones, hypercalcemia, or hyperparathyroidism;
5. History of severe liver disease, severe kidney disease, severe gastrointestinal disease, severe infectious diseases, severe sarcoidosis or other granulomatous diseases, severe mental illness, or any other condition considered unsuitable for participation judged by the clinic team;
6. Laboratory evaluation:

   * Blood calcium levels greater than or equal to the normal range for the clinical site's laboratory;
   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels higher than 3 times the normal range for the clinical site's laboratory;
   * eGFR \< 30 mL/(min·1.73m²);
7. Individuals currently taking vitamin D supplements (\>400 IU/day), calcium supplements (\>600 mg/day), yeast β-glucan supplements (\>250 mg/day), or those with a history of allergy or intolerance to vitamin D or prebiotic products;
8. Participation in other clinical trials within the past 3 months;
9. Planning to become pregnant within the next five years, or currently pregnant or breastfeeding.

Where it's running

• Guangxi Medical College
  Nanning, Guangxi, China Recruiting
• Kailuan General Hospital
  Tangshan, Hebei, China Recruiting
• Sinopharm Dongfeng General Hospital
  Shiyan, Hubei, China Recruiting
• Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: An Pan, PHD — School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Gang Liu, PHD
• Email: liugang026@hust.edu.cn
• Phone: 86-15926238366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.