Cardiometabolic Risk FactorsNCT07053657
Effect of Vitamin D on Cardiometabolic Risk in Chinese Adolescents
A study testing Dietary Supplement: Vitamin D3 in people with Cardiometabolic Risk Factors, run by Anhui Medical University at 2 sites in China.
Trial summary
The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on cardiometabolic risk in Chinese adolescents with vitamin D deficiency and normal-BMI or overweight/obesity. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Cardiometabolic Risk Factors
- What is being tested?
- Dietary Supplement: Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2025to 31 Dec 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Students whose caregivers signed informed consents;
- Students with serum 25(OH)D concentration of below 20 ng/mL;
- Students with normal-BMI or overweight/obesity.
Who cannot join
- Students with any disease that affects vitamin D metabolism (e.g., functional/organic brain disease, severe infectious disease, chronic gastrointestinal disease, hepatic or renal insufficiency, etc.);
- Students with known chronic disease (e.g., cardiovascular disease); use of vitamin D supplements in the past 3 months;
- Students with allergies to vitamin D or soybean oil ingredients.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Guangfu Middle School
Anqing, Anhui
Zhenxing School of Susong County
Anqing, Anhui
About this study
Official title: The Effect of Vitamin D on the Cardiometabolic Health of Chinese Adolescents
The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on cardiometabolic risk in Chinese adolescents with vitamin D deficiency and normal-BMI or overweight/obesity. The main question it aims to answer whether vitamin D3 supplementation can improve cardiovascular metabolic health.
Participants in the intervention group will receive vitamin D3. The control group will receive vitamin D placebo.
Researchers will compare the change in cardiometabolic risk from baseline to post-intervention at 12 weeks between the intervention and control groups in each BMI stratum.
Read the detailed description
This study was a 12-week, randomized, double-blind, placebo-controlled trial conducted at two middle schools in Anhui Province, China. The trial was designed to investigate the effects of vitamin D3 supplementation on cardiometabolic health among adolescents with vitamin D deficiency across different BMI categories.
A total of 306 adolescents were enrolled, including 169 with normal BMI and 137 with overweight/obesity. Participants were stratified by BMI category and randomly assigned to the vitamin D3 supplementation or placebo group within each stratum (simple randomization method). The randomization sequence was generated by an independent statistician, and allocation concealment was maintained using sequentially numbered, sealed envelopes. Participants and outcome assessors remained blinded to group assignments throughout the trial.
Participants received daily oral vitamin D3 supplementation or matching placebo capsules for 12 weeks. Supplements were distributed regularly, and adherence was assessed through self-reports. Potential adverse events were monitored throughout the intervention period.
Study assessments were conducted at baseline and at the end of the 12-week intervention. These assessments included anthropometric measurements, blood pressure measurements, and fasting blood sample collection for biochemical analyses. The effects of supplementation were evaluated by comparing changes in cardiometabolic health indicators between treatment groups within each BMI stratum. Statistical analyses followed the intention-to-treat principle, with additional adjustment for baseline measurements and prespecified covariates.
- Conditions
- Cardiometabolic Risk Factors
- Being tested
- Dietary Supplement: Vitamin D3, Dietary Supplement: Vitamin D3 placebo
- Keywords
- cardiometabolic risk, vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Vitamin D3Drug
2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.
Dietary Supplement: Vitamin D3 placeboDrug
Three capsules for 6 weeks, followed by one capsule for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Vitamin D3:
Vitamin D3: 2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks. Receives: Drug: Dietary Supplement: Vitamin D3 |
| Placebo Comparator | Placebo comparator | Vitamin D3 placebo:
Vitamin D3 placebo (i.e., soybean oil). Receives: Drug: Dietary Supplement: Vitamin D3 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiometabolic risk scores
The cardiovascular metabolic risk scores was the sum of the sex-specific standardized z-score for 5 indicators: WC, MAP (MAP=1/3*SBP+2/3*DBP), HDL-C (HDL-C value multiplied by -1), TG, and fasting glucose. A higher cardiometabolic risk scores indicates a higher individual cardiometabolic risk. Change in cardiometabolic risk scores from pre to post-intervention were compared between randomized groups, which was the primary outcome of this study
Measured: From randomization to the end of intervention at 12 weeks
Secondary outcomes (5)
BMI
Measurements were taken by trained researchers using a height and weight meter. The instrument was calibrated before the measurement and the subjects were asked to remove their shoes and wear light clothes during the measurement. We used weight in kilograms and height in metres to calculate BMI. The unit of BMI is kg/m^2, BMI=Weight/(Height*2) in kg/m^2.
Measured: From randomization to the end of intervention at 12 weeks
Waist circumference and Sum of skinfold thickness
Subcutaneous fat thickness was measured in the upper arm (at the midpoint of the line between the acromion point and the ulnar humerus), subscapularis (1 cm below the subscapularis) and abdomen (junction of the right midclavicular line and the umbilical level) using a skinfold thickness gauge after uniform training, with the results expressed in mm to one decimal place, and all of which required zeroing and pressure testing work of the skinfold thickness gauge before use. Waist circumference was measured using a corrected tape measure, circling horizontally along the midpoints of the lower edge of the ribs and the upper edge of the hip bone, and readings were recorded at the end of expiration to an accuracy of 0.1 cm.
Measured: From randomization to the end of intervention at 12 weeks
Blood pressure
The researchers measured systolic and diastolic blood pressure using an Omron HEM-7124 digital sphygmomanometer. Measurements were taken with the subject in a sitting position and started after 10 minutes of sitting still, with 2 measurements taken at 5 minute intervals. The average of the two measurements will be taken.
Measured: From randomization to the end of intervention at 12 weeks
Blood glucose and lipid
After each subject fasted overnight, the next day two professional nurses took their fasting blood samples by venipuncture, the blood samples were stored in an insulated box with ice packs, and all the samples were immediately transported to the laboratory to be tested by the professionals, and the indexes measured included fasting blood glucose, total cholesterol, triglycerides, HDL cholesterol and LDL cholesterol.
Measured: From randomization to the end of intervention at 12 weeks
TyG index
TyG index is considered an important predictor of IR risk and can be used to screen children and adolescents to prevent cardiovascular disease in adulthood. TyG index=ln (Triglyceride * Fasting bolld glucose) - ln (2).
Measured: From randomization to the end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start15 Sep 2025
- Primary completion15 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Mengyuan, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053657
- Sponsor's protocol ID
- 81250471
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be only used in a peer-reviewed journal in order to protect the privacy of the study participants.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D on the Cardiometabolic Health of Chinese Adolescents
- ClinicalTrials.gov ID
- NCT07053657
- Acronym / sponsor ID
- 81250471
- Conditions
- Cardiometabolic Risk Factors
- Keywords
- cardiometabolic risk, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Jul 2025 (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 controlled clinical trial is to investigate the effects of vitamin D3 supplementation on cardiometabolic risk in Chinese adolescents with vitamin D deficiency and normal-BMI or overweight/obesity. The main question it aims to answer whether vitamin D3 supplementation can improve cardiovascular metabolic health.
Participants in the intervention group will receive vitamin D3. The control group will receive vitamin D placebo.
Researchers will compare the change in cardiometabolic risk from baseline to post-intervention at 12 weeks between the intervention and control groups in each BMI stratum.
Detailed description
This study was a 12-week, randomized, double-blind, placebo-controlled trial conducted at two middle schools in Anhui Province, China. The trial was designed to investigate the effects of vitamin D3 supplementation on cardiometabolic health among adolescents with vitamin D deficiency across different BMI categories.
A total of 306 adolescents were enrolled, including 169 with normal BMI and 137 with overweight/obesity. Participants were stratified by BMI category and randomly assigned to the vitamin D3 supplementation or placebo group within each stratum (simple randomization method). The randomization sequence was generated by an independent statistician, and allocation concealment was maintained using sequentially numbered, sealed envelopes. Participants and outcome assessors remained blinded to group assignments throughout the trial.
Participants received daily oral vitamin D3 supplementation or matching placebo capsules for 12 weeks. Supplements were distributed regularly, and adherence was assessed through self-reports. Potential adverse events were monitored throughout the intervention period.
Study assessments were conducted at baseline and at the end of the 12-week intervention. These assessments included anthropometric measurements, blood pressure measurements, and fasting blood sample collection for biochemical analyses. The effects of supplementation were evaluated by comparing changes in cardiometabolic health indicators between treatment groups within each BMI stratum. Statistical analyses followed the intention-to-treat principle, with additional adjustment for baseline measurements and prespecified covariates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Dietary Supplement: Vitamin D3Vitamin D3: Vitamin D3: 2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks. |
| Placebo Comparator | Placebo comparator | Drug: Dietary Supplement: Vitamin D3 placeboVitamin D3 placebo: Vitamin D3 placebo (i.e., soybean oil). |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Students whose caregivers signed informed consents;
- Students with serum 25(OH)D concentration of below 20 ng/mL;
- Students with normal-BMI or overweight/obesity.
Key exclusion criteria (3 listed)
- Students with any disease that affects vitamin D metabolism (e.g., functional/organic brain disease, severe infectious disease, chronic gastrointestinal disease, hepatic or renal insufficiency, etc.);
- Students with known chronic disease (e.g., cardiovascular disease); use of vitamin D supplements in the past 3 months;
- Students with allergies to vitamin D or soybean oil ingredients.
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 |
|---|---|---|
| Dietary Supplement: Vitamin D32000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks. | Drug | Experimental |
| Dietary Supplement: Vitamin D3 placeboThree capsules for 6 weeks, followed by one capsule for 6 weeks. | Drug | Placebo Comparator |
Primary outcome
Change in cardiometabolic risk scores
Time frame: From randomization to the end of intervention at 12 weeks
The cardiovascular metabolic risk scores was the sum of the sex-specific standardized z-score for 5 indicators: WC, MAP (MAP=1/3*SBP+2/3*DBP), HDL-C (HDL-C value multiplied by -1), TG, and fasting glucose. A higher cardiometabolic risk scores indicates a higher individual cardiometabolic risk. Change in cardiometabolic risk scores from pre to post-intervention were compared between randomized groups, which was the primary outcome of this study
5 secondary outcomes
BMI
Time frame: From randomization to the end of intervention at 12 weeks
Waist circumference and Sum of skinfold thickness
Time frame: From randomization to the end of intervention at 12 weeks
Blood pressure
Time frame: From randomization to the end of intervention at 12 weeks
Blood glucose and lipid
Time frame: From randomization to the end of intervention at 12 weeks
TyG index
Time frame: From randomization to the end of intervention at 12 weeks
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 5 Nov 2026.
- Individual participant dataSharing planned: No. IPD will be only used in a peer-reviewed journal in order to protect the privacy of the study participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Vitamin D3 in people with Cardiometabolic Risk Factors, run by Anhui Medical University 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 3 inclusion and 3 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 5 Nov 2026. 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?
Change in cardiometabolic risk scores (time frame: From randomization to the end of intervention at 12 weeks). 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 5 Nov 2026.