Vitamin D to improve heart and metabolic health in overweight adolescents

The Improvement Effect of Vitamin D on the Cardiovascular Health of Overweight/Obesity Adolescents in China

This trial will test whether daily vitamin D3 supplements can improve heart and metabolic health in Chinese adolescents who are overweight or obese and have low vitamin D.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 10 Years to 16 Years
• Sex: All
• Sponsor: Anhui Medical University (Academic / other)
• Locations: 2 sites (Anqing, Anhui and 1 other locations)
• Trial ID: NCT07053657 on ClinicalTrials.gov

What this trial studies

Researchers will randomize 130 overweight or obese Chinese adolescents with serum 25(OH)D 12–20 ng/mL to receive either vitamin D3 or matching placebo for 12 weeks. The vitamin D arm receives 2000 IU per day for the first 6 weeks followed by 800 IU per day for the next 6 weeks, with dispensing visits every two weeks then every three weeks, and the placebo arm follows the same schedule. The primary outcome is the change in a composite cardiometabolic risk score from baseline to 12 weeks, with secondary measures likely including lipids, blood pressure, and insulin resistance. Participants with conditions affecting vitamin D metabolism, known chronic disease, recent vitamin D use, or allergies to study ingredients are excluded.

Who should consider this trial

Good fit: Ideal candidates are overweight or obese adolescents in Anhui with serum 25(OH)D concentrations of 12–20 ng/mL whose caregivers can provide informed consent.

Not a fit: Adolescents with normal or high vitamin D levels, chronic diseases affecting vitamin D metabolism, recent vitamin D supplement use, or allergies to vitamin D formulations are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this could offer a low-cost way to improve cardiometabolic risk markers in vitamin D–deficient overweight adolescents.

How similar studies have performed: Previous trials of vitamin D for cardiometabolic outcomes have shown mixed and often modest effects, so this approach is not yet proven and is being tested specifically in Chinese adolescents.

Eligibility criteria

Inclusion Criteria:

1. Students whose caregivers signed informed consents;
2. Students with serum 25(OH)D concentration of 12-20 ng/mL;
3. Students with overweight or obesity.

Exclusion Criteria:

1. 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.);
2. Students with known chronic disease (e.g., cardiovascular disease); use of vitamin D supplements in the past 3 months;
3. Students with allergies to vitamin D or soybean oil ingredients.

Where this trial is running

Anqing, Anhui and 1 other locations

• Anhui Medical University — Anqing, Anhui, China (Recruiting)
• Anhui Medical University — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Puyu Su, PhD

Conditions Cardiometabolic Risk Factors; cardiometabolic risk; vitamin D