The Improvement Effect of Vitamin D on the Cardiovascular Health of Overweight/Obesity Adolescents in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change in cardiometabolic risk scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Students whose caregivers signed informed consents;
- •Students with serum 25(OH)D concentration of 12-20 ng/mL;
- •Students with overweight or obesity.
排除标准
- •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.
研究组 & 干预措施
Placebo Comparator
Vitamin D3 placebo:
Vitamin D3 placebo (i.e., soybean oil).
干预措施: Dietary Supplement: Vitamin D3 placebo (Drug)
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.
干预措施: Dietary Supplement: Vitamin D3 (Drug)
结局指标
主要结局
Change in cardiometabolic risk scores
时间窗: From 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
Change in cardiometabolic risk scores
时间窗: From 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
次要结局
- 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)
- BMI(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)
- Waist circumference and Sum of skinfold thickness(From randomization to the end of intervention at 3 months)
- TyG index(From randomization to the end of intervention at 3 months)
研究者
Yuan Mengyuan
Doctor
Anhui Medical University