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Daily supplements may cut heart risks for diabetes patients

NCT ID NCT06351566

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether taking daily vitamin D3 and prebiotics (inulin) for six months could improve heart health markers in 190 adults with type 2 diabetes. Researchers measured blood sugar control, cholesterol, and gut bacteria changes. The goal is to find simple dietary ways to lower cardiovascular risk in this population.

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 prebiotics (inulin)
What this could lead to
If it works, this could point toward a simple dietary supplement strategy to help manage heart disease risk in people with type 2 diabetes.
What could go wrong
This is a small, completed study, so results may not apply to everyone. Supplements are not a substitute for standard diabetes care.

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

190 people

The number who actually took part.

Started

Apr 2024

Finished

Aug 2025

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

35 to 70 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 (meeting any of the following criteria): Physician-diagnosed type 2 diabetes, use of oral hypoglycemic medication or insulin, fasting blood glucose ≥ 7.0 mmol/L, HbA1c ≥ 6.5% (48 nmol/L), 2-hour plasma glucose (2hPG) ≥ 11.1 mmol/L. 2. Men aged 35-70 years or women aged 35-70 years. 3. Convenient access to study centers. 4. Written informed consent obtained before any trial-related activities. Exclusion Criteria: 1. History of macrovascular diseases (including Coronary heart disease, myocardial infarction, heart failure, stroke, transient ischemic attack, peripheral vascular disease, post coronary artery bypass surgery). 2. History of diabetic microvascular complications (including diabetic nephropathy, diabetic retinopathy, or diabetic neuropathy). 3. History of other cardiovascular diseases (including aortic stenosis, transient ischemic attack, angina pectoris, cardiac arrest, complex ventricular arrhythmias, or surgery of cardiovascular diseases). 4. History of cancer, excluding non-melanoma skin cancer or cancers with a good prognosis (such as stage 1 cervical cancer). 5. Severe liver disease (such as cirrhosis), severe kidney disease (such as renal failure or requiring dialysis), or severe gastrointestinal disease (such as a history of bowel obstruction). 6. Kidney stones, hypercalcemia, parathyroid hormone abnormality. 7. Sarcoidosis or other granulomatous diseases, such as active chronic pulmonary tuberculosis or Wegener's granulomatosis. 8. Any mental disorders, such as schizophrenia, other mental disorders, or bipolar disorder. 9. Individuals with infectious diseases such as HIV/AIDS, viral hepatitis. 10. Individuals requiring long-term hospitalization or those with other serious illnesses requiring immediate hospital treatment. 11. In the past 3 months, those who have taken any vitamin D supplements exceeding 400 IU/day, calcium supplements exceeding 600 mg/day, prebiotics exceeding 2 g/day, or probiotics exceeding 10\^8 colony forming units/day. 12. History of allergy or intolerance to vitamin D, prebiotics, or starch. 13. Individuals with unhealthy habits: heavy alcohol consumption (\>80 grams/day for males, \>40 grams/day for females) or smoking (\>40 cigarettes/day). 14. Individuals with cognitive impairment, inability to communicate properly, inability to take care of themselves, or those with mobility issues. 15. Those having participated in other clinical trials or studies in the past 3 months. 16. Those who are intent to become pregnant within the next two years, are currently pregnant, or breastfeeding. 17. Individuals with abnormal laboratory tests and clinical manifestations who are judged by the researcher to be unsuitable for participation.

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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.

Contacts and locations

Locations

  • Bao'an Center Hosipital of Shenzhen

    Shenzhen, Guangdong, China

  • School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China

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