Diabetes Mellitus, Type 2NCT06351566
Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes
A study testing Vitamin D3 and Prebiotics in people with Diabetes Mellitus, Type 2, run by Huazhong University of Science and Technology at 2 sites in China.
Trial summary
The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vitamin D3 and Prebiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 2 sitesChina
- Study dates
- 25 Apr 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Men aged 35-70 years or women aged 35-70 years.
- Convenient access to study centers.
- Written informed consent obtained before any trial-related activities.
Who cannot join
- History of macrovascular diseases (including Coronary heart disease, myocardial infarction, heart failure, stroke, transient ischemic attack, peripheral vascular disease, post coronary artery bypass surgery).
- History of diabetic microvascular complications (including diabetic nephropathy, diabetic retinopathy, or diabetic neuropathy).
- History of other cardiovascular diseases (including aortic stenosis, transient ischemic attack, angina pectoris, cardiac arrest, complex ventricular arrhythmias, or surgery of cardiovascular diseases).
- History of cancer, excluding non-melanoma skin cancer or cancers with a good prognosis (such as stage 1 cervical cancer).
- 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).
- Kidney stones, hypercalcemia, parathyroid hormone abnormality.
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- Sarcoidosis or other granulomatous diseases, such as active chronic pulmonary tuberculosis or Wegener's granulomatosis.
- Any mental disorders, such as schizophrenia, other mental disorders, or bipolar disorder.
- Individuals with infectious diseases such as HIV/AIDS, viral hepatitis.
- Individuals requiring long-term hospitalization or those with other serious illnesses requiring immediate hospital treatment.
- 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.
- History of allergy or intolerance to vitamin D, prebiotics, or starch.
- Individuals with unhealthy habits: heavy alcohol consumption (>80 grams/day for males, >40 grams/day for females) or smoking (>40 cigarettes/day).
- Individuals with cognitive impairment, inability to communicate properly, inability to take care of themselves, or those with mobility issues.
- Those having participated in other clinical trials or studies in the past 3 months.
- Those who are intent to become pregnant within the next two years, are currently pregnant, or breastfeeding.
- Individuals with abnormal laboratory tests and clinical manifestations who are judged by the researcher to be unsuitable for participation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Bao'an Center Hosipital of Shenzhen
Shenzhen, Guangdong
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Double-Blind Controlled Trial
The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors.
Read the detailed description
The goal of this randomized, double-blind, placebo-controlled trial, with a two-by-two factorial design in individuals with type 2 diabetes (T2D) is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease (CVD) risk factors.
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
- Diabetes Mellitus, Type 2
- Being tested
- Vitamin D3, Prebiotics, Vitamin D3 placebo, Prebiotics placebo
- Keywords
- Vitamin D, Prebiotics, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Blood Glucose, Lipids
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Cholecalciferol
Vitamin D3 (cholecalciferol), 1600 IU per day.
PrebioticsDietary supplement
Also called Inulin
Prebiotics (inulin), 10g per day.
Vitamin D3 placeboDietary supplement
Vitamin D3 placebo
Prebiotics placeboDietary supplement
Prebiotics placebo, 10g per day.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 + Prebiotics | Active comparator | Not described Receives: Drug: Vitamin D3; Dietary Supplement: Prebiotics |
| Vitamin D3 + Prebiotics placebo | Active comparator | Not described Receives: Drug: Vitamin D3; Dietary Supplement: Prebiotics placebo |
| Prebiotics +Vitamin D3 placebo | Active comparator | Not described Receives: Dietary Supplement: Prebiotics; Dietary Supplement: Vitamin D3 placebo |
| Vitamin D3 placebo + Prebiotics placebo | Placebo comparator | Not described Receives: Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Prebiotics placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
Concentration of HbA1c, measured in the percentage of hemoglobin
Measured: 6 months
Concentration of blood lipids
Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), measured in mmol/L
Measured: 6 months
Metagenomic analysis of the gut microbiota
The diversity of the gut microbiota will be assessed by high-quality whole-metagenomic sequencing
Measured: 6 months
Secondary outcomes (11)
Concentration of fasting glucose
Concentration of fasting glucose, measured in mmol/L
Measured: 6 months
Concentration of fasting insulin
Concentration of fasting insulin, measured in milli-International unit/L
Measured: 6 months
Systolic and diastolic blood pressure
The level of systolic blood pressure and diastolic blood pressure, measured in mmHg
Measured: 6 months
Estimated glomerular filtration rate (eGFR)
Calculating the level of eGFR using Chronic Kidney Disease Epidemiology Collaboration equation
Measured: 6 months
Concentration of C-reactive protein (CRP)
Concentration of CRP, measured in mg/dL
Measured: 6 months
Concentration of procalcitonin
Concentration of procalcitonin, measured in pg/mL
Measured: 6 months
Concentration of interleukin-6 (IL-6)
Concentration of IL-6, measured in pg/mL
Measured: 6 months
Concentration of serum 25(OH)D
Concentration of serum 25(OH)D concentrations, measured in nmol/L
Measured: 6 months
Body weight
Weight in kilograms
Measured: 6 months
Waist circumference
Waist circumference in centimeters
Measured: 6 months
Hip circumference
Hip circumference in centimeters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start25 Apr 2024
- Primary completion31 Dec 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, An Pan, Huazhong University of Science and Technology
- Investigators
- Gang Liu, PHD, Principal investigator, School of Public Health, Tongji Medical College, Huazhong University of Science and TechnologyAn Pan, PHD, Principal investigator, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351566
- Sponsor's protocol ID
- VD3, Prebiotics in Diabetes
- Status last verified
- Sep 2025
- First submitted
- 8 Mar 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06351566
- Acronym / sponsor ID
- VD3, Prebiotics in Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Vitamin D, Prebiotics, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Blood Glucose, Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors.
Detailed description
The goal of this randomized, double-blind, placebo-controlled trial, with a two-by-two factorial design in individuals with type 2 diabetes (T2D) is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease (CVD) risk factors.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 + Prebiotics | Active comparator | Drug: Vitamin D3, Dietary Supplement: Prebiotics |
| Vitamin D3 + Prebiotics placebo | Active comparator | Drug: Vitamin D3, Dietary Supplement: Prebiotics placebo |
| Prebiotics +Vitamin D3 placebo | Active comparator | Dietary Supplement: Prebiotics, Dietary Supplement: Vitamin D3 placebo |
| Vitamin D3 placebo + Prebiotics placebo | Placebo comparator | Dietary Supplement: Vitamin D3 placebo, Dietary Supplement: Prebiotics placebo |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Men aged 35-70 years or women aged 35-70 years.
- Convenient access to study centers.
- Written informed consent obtained before any trial-related activities.
Key exclusion criteria (17 listed)
- History of macrovascular diseases (including Coronary heart disease, myocardial infarction, heart failure, stroke, transient ischemic attack, peripheral vascular disease, post coronary artery bypass surgery).
- History of diabetic microvascular complications (including diabetic nephropathy, diabetic retinopathy, or diabetic neuropathy).
- History of other cardiovascular diseases (including aortic stenosis, transient ischemic attack, angina pectoris, cardiac arrest, complex ventricular arrhythmias, or surgery of cardiovascular diseases).
- History of cancer, excluding non-melanoma skin cancer or cancers with a good prognosis (such as stage 1 cervical cancer).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: CholecalciferolVitamin D3 (cholecalciferol), 1600 IU per day. | Drug | Vitamin D3 + Prebiotics, Vitamin D3 + Prebiotics placebo |
| PrebioticsAlso: InulinPrebiotics (inulin), 10g per day. | Dietary supplement | Prebiotics +Vitamin D3 placebo, Vitamin D3 + Prebiotics |
| Vitamin D3 placeboVitamin D3 placebo | Dietary supplement | Prebiotics +Vitamin D3 placebo, Vitamin D3 placebo + Prebiotics placebo |
| Prebiotics placeboPrebiotics placebo, 10g per day. | Dietary supplement | Vitamin D3 + Prebiotics placebo, Vitamin D3 placebo + Prebiotics placebo |
Primary outcome
Glycated hemoglobin (HbA1c)
Time frame: 6 months
Concentration of HbA1c, measured in the percentage of hemoglobin
Concentration of blood lipids
Time frame: 6 months
Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), measured in mmol/L
Metagenomic analysis of the gut microbiota
Time frame: 6 months
The diversity of the gut microbiota will be assessed by high-quality whole-metagenomic sequencing
11 secondary outcomes
Concentration of fasting glucose
Time frame: 6 months
Concentration of fasting insulin
Time frame: 6 months
Systolic and diastolic blood pressure
Time frame: 6 months
Estimated glomerular filtration rate (eGFR)
Time frame: 6 months
Concentration of C-reactive protein (CRP)
Time frame: 6 months
Concentration of procalcitonin
Time frame: 6 months
Concentration of interleukin-6 (IL-6)
Time frame: 6 months
Concentration of serum 25(OH)D
Time frame: 6 months
Body weight
Time frame: 6 months
Waist circumference
Time frame: 6 months
Hip circumference
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Liu, PHD principal investigator
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
An Pan, PHD principal investigator
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 and Prebiotics in people with Diabetes Mellitus, Type 2, run by Huazhong University of Science and Technology at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (HbA1c) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.