Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents: Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change from baseline in Flow Mediated Dilation (%) at the brachial artery
研究概览
简要总结
The main objective of this study is to analyze in a population of obese adolescents, the effect of vitamin D3 supplementation in addition to lifestyle and dietary management on vascular function assessed by the change between M0 and M3 of endothelium-dependent vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).
详细描述
The secondary objectives of this study are:
A. To analyze in obese adolescents, the effect of the addition of vitamin D3 supplementation on metabolic and vascular function.
B. To compare the relationships between food intake, metabolic, inflammatory, oxidative stress and vitamin D status, and vascular dysfunction between obese and normal weight subjects.
C. To evaluate the effects of sun exposure variations on relationships described in Objective B by comparing the observed parameters at baseline and at the end of the three month follow-up period, in non-supplemented obese adolescents and adolescents of normal weight.
D. To identify biomarkers (metabolic signatures) in obese adolescents associated with vitamin D deficiency and vascular function.
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, Investigator)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient's legal representatives must have given their informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Sexual maturation of at least Tanner stage 2
- •Inclusion criteria for the patient population
- •The subject has a body mass index corresponding to grade 2 obesity according to the curves described by Rolland-Cachera et al (1991)
- •Absence of at least 5% of total weight over the last 3 months
- •Inclusion criteria for the control population
- •The subject has a body mass index < 90th percentile
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection
- •The patient's legal representative(s) refuse(s) to sign the consent
- •It is impossible to correctly inform the patient or his/her legal representative(s)
- •The patient has a contraindication for physical activity (joint, heart or other)
- •The subject does at least 3 hours of extracurricular physical activity per week
- •The subject has a concomitant illness, a history of first-degree cardiovascular disease, abnormal glucose tolerance (pre-diabetes or diabetes).
- •Active smoking
- •Known dyslipidemia (particularly hypercholesterolemia).
- •The subject regularly takes food and vitamin supplements and refuses to stop taking these during the study (in case of disruption of these supplements, a wash-out stopping period of 3 weeks is required).
- •BMI corresponding to a grade 1 obesity according to the Rolland-Cachera et al. (1991) curves.
- •Secondary or known genetic obesity.
- •Known hypersensitivity to vitamin D.
- •Hypercalcemia, hypercalciuria, calcium lithiasis
研究组 & 干预措施
Non-Obese group
Non-obese patients will be recruited and frequency matched to obese groups according to sex and level of sexual maturation.
Intervention: Normal control
干预措施: Normal control (Other)
Obese group, Vitamin D
Subjects randomized to this group will receive vitamin D supplementation. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.
Intervention: 3 months lifestyle and dietary management Intervention: Vitamin D supplementation
干预措施: Vitamin D supplementation (Drug)
Obese group, Vitamin D
Subjects randomized to this group will receive vitamin D supplementation. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.
Intervention: 3 months lifestyle and dietary management Intervention: Vitamin D supplementation
干预措施: 3 months lifestyle and dietary management (Other)
Obese group, placebo
Subjects randomized to this group will receive a placebo supplement. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.
Intervention: 3 months lifestyle and dietary management Intervention: Placebo
干预措施: Placebo (Drug)
Obese group, placebo
Subjects randomized to this group will receive a placebo supplement. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.
Intervention: 3 months lifestyle and dietary management Intervention: Placebo
干预措施: 3 months lifestyle and dietary management (Other)
结局指标
主要结局
Change from baseline in Flow Mediated Dilation (%) at the brachial artery
时间窗: 3 months
次要结局
- Change from baseline in Nitrate Mediated Dilation (%) at the brachial artery(3 months)
- Change from baseline in arterial wave speed (m*s^-1)(3 months)
- Change from baseline in brachial compliance (mm^2mmHg^-1)(3 months)
- Usual Vitamin D intake according to food questionnaire(Baseline)
- Change from baseline in Triglyceride levels(3 months)
- Change from baseline in adiponectin (pg*mL^-1)(3 months)
- Change from baseline in serum calcium levels (mmol*L^-1)(3 months)
- Change from baseline in Homeostatic model assessment Insulin Resistance(3 months)
- Change from baseline in the ratio Low Density Lipoprotein/High Density Lipoprotein(3 months)
- Change from baseline in SuperOxyde Dismutase (U*gHb^-1)(3 months)
- Change from baseline in Isoprostanes (ng*L^-1)(3 months)
- Change from baseline in nitrite-nitrate (µmol*L^-1)(3 months)
- Change from baseline in PAI-1 (µmol*L^-1)(3 months)
- Metabolomic profile(3 months)
- Change from baseline in TNF-alpha (pg*mL^-1)(3 months)
- Change from baseline in carotid compliance (mm^2mmHg^-1)(3 months)
- Change from baseline in blood 25(OH)D levels (mmol*L^-1)(3 months)
- Change from baseline in blood parathyroid hormone levels (mmol*L^-1)(3 months)
- Change from baseline in High sensitivity C-reactive protein (pg*mL^-1)(3 months)
- Change from baseline in leptin (pg*mL^-1)(3 months)
- Change from baseline in blood total protein levels (g*L^-1)(3 months)
- Change from baseline in Acetylcholine-Cutaneous Blood Flow peak(3 months)
- Change from baseline in Sodium nitroprussiate-Cutaneous Blood Flow peak (%)(3 months)
- Change from baseline in Insulin-Cutaneous Blood Flow peak (%)(3 months)
- Change from baseline in IL-6 (pg*mL^-1)(3 months)