Effects of Vitamin D3 and prebiotics on heart health in people with type 2 diabetes

Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Double-Blind Controlled Trial

This study is testing if taking vitamin D3 and prebiotics every day can improve heart health in people with type 2 diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 35 Years to 70 Years
• Sex: All
• Sponsor: Huazhong University of Science and Technology (Academic / other)
• Locations: 2 sites (Shenzhen, Guangdong and 1 other locations)
• Trial ID: NCT06351566 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial aims to evaluate the impact of daily supplementation with vitamin D3 (1600 IU) and prebiotics (10 grams) on cardiovascular disease risk factors in individuals with type 2 diabetes. Approximately 200 participants will be randomly assigned to one of four groups to receive either the active supplements or placebos over a six-month period. The study will collect data on participants' health status, lifestyle habits, and sociodemographic factors to assess the efficacy of the interventions. Participants must meet specific inclusion criteria and have no history of significant cardiovascular or diabetic complications.

Who should consider this trial

Good fit: Ideal candidates for this study are men and women aged 35-70 years diagnosed with type 2 diabetes.

Not a fit: Patients with a history of cardiovascular diseases or diabetic complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular health and reduced risk factors for patients with type 2 diabetes.

How similar studies have performed: Other studies have shown promising results with vitamin D and prebiotics in improving health outcomes, but this specific combination in type 2 diabetes is relatively novel.

Eligibility criteria

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.

Where this trial is running

Shenzhen, Guangdong and 1 other locations

• Bao'an Center Hosipital of Shenzhen — Shenzhen, Guangdong, China (Recruiting)
• School of Public Health, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Gang Liu, PHD — School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Gang Liu, PHD

Conditions Diabetes Mellitus, Type 2; Vitamin D; Prebiotics; Cardiovascular Diseases; Blood Glucose; Lipids