Actively Recruiting

Phase Not Applicable
Age: 10Years - 16Years
All Genders
ID07053657

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

Led by Anhui Medical University · Updated on 2025-11-17

130

Participants Needed

2

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether vitamin D3 supplementation can improve cardiovascular metabolic health in Chinese adolescents who are overweight or obese and have vitamin D deficiency. This randomized controlled trial aims to compare changes in cardiometabolic risk between those receiving vitamin D3 and those receiving a placebo over a 12-week period. Participants will be randomly assigned to receive either vitamin D3 supplements or a placebo. The vitamin D3 group will take 2000 IU daily for the first 6 weeks, followed by 800 IU daily for the next 6 weeks. The placebo group will receive matching placebo capsules on the same schedule. For the first 6 weeks, doses are given every two weeks, then every three weeks for the following 6 weeks. During the study, researchers will monitor changes in cardiometabolic risk scores from the start to the end of the 12-week intervention. Additional measurements include body mass index, waist circumference, skinfold thickness, blood pressure, blood glucose, blood lipids, and the TyG index. Participants’ health and vitamin D levels will be assessed throughout to evaluate the effects of supplementation.

CONDITIONS

Brief Title

Effect of Vitamin D on Cardiovascular Metabolic Risk in Overweight/Obesity Adolescents in China

Who Can Participate

Age: 10Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Students whose caregivers signed informed consents
  • Students with serum 25(OH)D concentration of 12-20 ng/mL
  • Students with overweight or obesity
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 weeks

Participants receive daily vitamin D3 supplementation or placebo for 12 weeks to evaluate effects on cardiovascular metabolic health.

Visits every 2 weeks during the first 6 weeks, then every 3 weeks for the next 6 weeks

Trial Site Locations

Total: 2 locations

1

Anhui Medical University

Anqing, Anhui, China

Actively Recruiting

2

Anhui Medical University

Hefei, Anhui, China

Actively Recruiting

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Research Team

P

Puyu Su, PhD

P

Puyu Su, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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