Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07053657

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 16 Years

SexAll

Healthy volunteersNot accepted

ConditionCardiometabolic Risk Factors

Full registry 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.

Treatments and study arms

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.

Dietary Supplement: Vitamin D3 placebo

Drug

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

Primary outcomes

Change in cardiometabolic risk scoresFrom randomization to the end of intervention at 3 months

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

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Anhui Medical University🇨🇳 Anqing, Anhui, China

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Anhui Medical University🇨🇳 Hefei, Anhui, China

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Zhizhong WangContact

Email · Call +86 18956075017

Jiehua DingContact

Email · Call +86 13866055269