Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes
NCT ID: NCT06351566
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
190 participants
INTERVENTIONAL
2024-04-25
2025-08-31
Brief Summary
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Detailed Description
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About 200 subjects with T2D will be included in this study. All participants will provide written informed consent before randomization. Eligible participants must have no history of cancer, macrovascular or microvascular complications at trial entry, and they are required to agree to limited use of vitamin D, prebiotics, probiotics, or synbiotic supplementations, as well as to convenient access to study centers. Safety exclusions include renal failure or dialysis, cirrhosis, history of hypercalcemia, or other conditions that would preclude participation.
Eligible participants will be assigned by chance to one of four groups: (1) daily vitamin D3 (1600 IU) and prebiotics (10 grams); (2) daily vitamin D3 (1600 IU) and prebiotics placebo (10 grams); (3) daily vitamin D3 placebo and prebiotics (10 grams); or (4) daily vitamin D3 placebo (1600 IU) and prebiotics placebo (10 grams). Randomization will be computer-generated within sex and age groups.
During the run-in period, baseline questionnaires will be designed to collect data on sociodemographic factors, lifestyle habits, health status, and medical conditions, and participants will undergo physical measurements at baseline. Blood, urine, and faeces samples will also be obtained at study centers.
Participants in all groups will be required to take two capsules each day, containing either vitamin D3 or vitamin D3 placebo, as well as a strip of prebiotics powder (10 g per strip, brew with warm water) or prebiotics placebo. Participants will receive their capsules and powder at study centers each month.
Participants will complete follow-up questionnaires, including information on adherence to trial regimens, outside use of supplementations, development of major illnesses, and potential side effects of the trial agents, at 3 months and 6 months after randomization. Physical measurements and collection of biological samples will be conducted at study centers 6 months after randomization.
The primary outcomes, including glycated hemoglobin (HbA1c) and blood lipids (such as total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), will be measured using blood samples. The data will be collected and analyzed.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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Vitamin D3 + Prebiotics
Vitamin D3
Vitamin D3 (cholecalciferol), 1600 IU per day.
Prebiotics
Prebiotics (inulin), 10g per day.
Vitamin D3 + Prebiotics placebo
Vitamin D3
Vitamin D3 (cholecalciferol), 1600 IU per day.
Prebiotics placebo
Prebiotics placebo, 10g per day.
Prebiotics +Vitamin D3 placebo
Prebiotics
Prebiotics (inulin), 10g per day.
Vitamin D3 placebo
Vitamin D3 placebo
Vitamin D3 placebo + Prebiotics placebo
Vitamin D3 placebo
Vitamin D3 placebo
Prebiotics placebo
Prebiotics placebo, 10g per day.
Interventions
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Vitamin D3
Vitamin D3 (cholecalciferol), 1600 IU per day.
Prebiotics
Prebiotics (inulin), 10g per day.
Vitamin D3 placebo
Vitamin D3 placebo
Prebiotics placebo
Prebiotics placebo, 10g per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
35 Years
70 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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An Pan
Professor
Principal Investigators
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Gang Liu, PHD
Role: PRINCIPAL_INVESTIGATOR
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
An Pan, PHD
Role: PRINCIPAL_INVESTIGATOR
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
Locations
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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
Countries
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Other Identifiers
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VD3, Prebiotics in Diabetes
Identifier Type: -
Identifier Source: org_study_id
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