Effect of Vitamin D on Cardiovascular Metabolic Risk in Overweight/Obesity Adolescents in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary Supplement: Vitamin D3, Dietary Supplement: Vitamin D3 placebo.
- Who it may be relevant to
- Registry conditions: Cardiometabolic Risk Factors. Basic parameters: 10 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Improvement Effect of Vitamin D on the Cardiovascular Health of Overweight/Obesity Adolescents in China
Overview
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.
Interventions
- Drug 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. - Drug Dietary Supplement: Vitamin D3 placebo
Three capsules for 6 weeks, followed by one capsule for 6 weeks.
Primary outcome measures
- Change in cardiometabolic risk scores [Time frame: From randomization to the end of intervention at 3 months]
Secondary outcome measures (5)
- BMI [Time frame: From randomization to the end of intervention at 3 months]
- Waist circumference and Sum of skinfold thickness [Time frame: From randomization to the end of intervention at 3 months]
- Blood pressure [Time frame: From randomization to the end of intervention at 3 months]
- Blood glucose and lipid [Time frame: From randomization to the end of intervention at 3 months]
- TyG index [Time frame: From randomization to the end of intervention at 3 months]
Eligibility criteria
Inclusion criteria
- Students whose caregivers signed informed consents;
- Students with serum 25(OH)D concentration of 12-20 ng/mL;
- Students with overweight or obesity.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Anhui Medical University — Anqing
- Anhui Medical University — Hefei
Identifiers
NCT: NCT07053657 · 81250471