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

NCT07053657 | Recruiting

• 1 other identifier: 81250471
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiometabolic Risk Factors

Keywords

cardiometabolic risk; vitamin D

Outcome Measures

Primary Outcomes (1)

• 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

  From randomization to the end of intervention at 3 months

Secondary Outcomes (5)

• BMI

  From randomization to the end of intervention at 3 months

• Waist circumference and Sum of skinfold thickness

  From randomization to the end of intervention at 3 months

• Blood pressure

  From randomization to the end of intervention at 3 months

• Blood glucose and lipid

  From randomization to the end of intervention at 3 months

• TyG index

  From randomization to the end of intervention at 3 months

Study Arms (2)

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.

Drug: Dietary Supplement: Vitamin D3

Placebo Comparator

PLACEBO COMPARATOR

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

Drug: Dietary Supplement: Vitamin D3 placebo

Interventions

Dietary Supplement: Vitamin D3 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.

Experimental

Dietary Supplement: Vitamin D3 placebo DRUG

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

Placebo Comparator

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (2)

Anhui Medical University

Anqing, Anhui, China

RECRUITING

Anhui Medical University

Hefei, Anhui, China

RECRUITING

Central Study Contacts

Puyu Su, PhD

CONTACT

86-13856058551; supuyu@ahmu.edu.cn

Puyu Su, Professor

CONTACT

86-13856058551; supuyu@ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 8, 2025
• Study Start: September 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)