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

NCT ID: NCT07053657

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2025-12-31

Brief 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 overweight/obesity and vitamin D deficiency. 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.

Detailed Description

Investigators will conduct a randomized controlled trial to examine whether vitamin D3 supplementation can improve cardiovascular metabolic health. A total of 130 participants will be recruited from two middle schools. Inclusion criteria were students with both students and parents signing a paper version of the informed consent form, overweight/obesity and serum 25(OH)D concentration of 12~20ng/ml. Exclusion criteria are any disease that affects vitamin D metabolism (e.g., functional/organic brain disease, severe infectious disease, chronic gastrointestinal disease, hepatic or renal insufficiency, etc.); known chronic disease (e.g., cardiovascular disease); use of vitamin D supplements in the past 3 months; and adolescents with allergies to vitamin D or soybean oil ingredients. Participants will be randomly assigned into a supplementation or placebo group. Supplementation arm will receive oral dose 2000 IU vitamin D3 per day for 6 weeks and followed by 800 IU per day for 6 weeks, placebo arm will receive placebo every day for 12 weeks. For the first 6 weeks, vitamin D or placebo will be administrated every two weeks. For the next 6 weeks, vitamin D or placebo will be administrated every 3 weeks. The primary outcome of this study is to compare the change of cardiometabolic risk between supplementation or placebo group from post-intervention 12 weeks.

Conditions

Cardiometabolic Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary Supplement: Vitamin D3

Intervention Type: DRUG

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

Vitamin D3 placebo:

Vitamin D3 placebo (i.e., soybean oil).

Group Type: PLACEBO_COMPARATOR

Dietary Supplement: Vitamin D3 placebo

Intervention Type: DRUG

Three capsules for 6 weeks, followed by one capsule for 6 weeks.

Interventions

Dietary Supplement: 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.

Intervention Type: DRUG

Dietary Supplement: Vitamin D3 placebo

Three capsules for 6 weeks, followed by one capsule for 6 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuan Mengyuan

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Medical University

Anqing, Anhui, China

Site Status: RECRUITING

Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Puyu Su, PhD

Role: CONTACT

supuyu@ahmu.edu.cn

86-13856058551

Puyu Su, Professor

Role: CONTACT

supuyu@ahmu.edu.cn

86-13856058551

Facility Contacts

Zhizhong Wang

Role: primary

2214750343@qq.com

+86 18956075017

Jiehua Ding

Role: backup

1961289909@qq.com

+86 13866055269

Other Identifiers

81250471

Identifier Type: -

Identifier Source: org_study_id