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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 8000 to 2500v4 Show 4 more changesShow less
    • Primary endpoints: 1 to 2
    • Secondary endpoints: 7 to 29
    • Study description expanded, about 54 words
    • Study title expanded, about 4 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 5
    • Start date changed from estimate of Mar 20, 2025 to Apr 8, 2025
    v3
  3. Start date: Mar 1, 2025 to Mar 20, 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06861062
Lead Sponsor Huazhong University of Science and Technology
Conditions
(from sponsor)		 Diabetes Mellitus, Type 2
Related terms Cardiovascular Diseases, Diabetes Mellitus, Type 2
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov