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Can vitamin d and yeast fiber tame diabetes and protect the heart?

NCT ID NCT06861062

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether taking vitamin D3 or yeast beta-glucan daily for two years can improve blood sugar control and lower the 10-year risk of heart disease in 2,500 adults aged 40–79 with type 2 diabetes. Participants will be randomly assigned to receive one of the supplements or a placebo, and researchers will track changes in HbA1c and heart risk scores. The goal is to find a simple, low-cost way to help manage diabetes and prevent complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vitamin D3 (cholecalciferol) and yeast beta-glucan
What this could lead to
If it works, this could show that simple daily supplements help manage blood sugar and lower heart disease risk in people with type 2 diabetes.
What could go wrong
This is a large but early-stage trial with no phase designation. Supplements may have only small effects, and results may not apply to everyone with diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Guangxi Medical College

    RECRUITING

    Nanning, Guangxi, China

  • Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Kailuan General Hospital

    RECRUITING

    Tangshan, Hebei, China

  • Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Sinopharm Dongfeng General Hospital

    RECRUITING

    Shiyan, Hubei, China

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