The Role of Vitamin D Supplementation in the Prevention of Cardiovascular Risk Factors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in insulin sensitivity (M value)
研究概览
简要总结
Hypovitaminosis D is highly prevalent in the general population, particularly in obese individuals. Besides being associated with obesity, vitamin D deficiency seems to be involved in the pathogenesis of insulin resistance and low-grade chronic inflammation. In addition, it has been reported that individuals with low vitamin D levels are at increased risk for cardiovascular diseases. A healthy diet and weight loss are cornerstones in the prevention of cardiovascular diseases. Vitamin D supplementation could increase the beneficial effects of these lifestyle interventions. The purpose of this study is to assess whether vitamin D supplementation in conjunction with a hypocaloric diet improves the cardiometabolic profile of overweight/obese subjects to a greater extent than diet alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI≥25 kg/m2
排除标准
- •Diabetes mellitus
- •Chronic kidney disease
- •Liver disease
- •Cholestasis
- •Chronic bowel disease
- •Primary or secondary hyperparathyroidism
- •Treatment with drugs that may affect insulin sensitivity, weight or calcium/vitamin D metabolism
- •Laxative abuse
- •Changes >10% of usual body weight in the previous 6 months
- •Alcohol or illicit drug abuse
- •Pregnancy
研究组 & 干预措施
Vitamin D and Diet
Cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL oral solution. 25,000 I.U. (one bottle) per week.
Hypocaloric diet
干预措施: Vitamin D (Drug)
Placebo & Diet
Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week.
Hypocaloric diet
干预措施: Placebo (for vitamin D) (Drug)
结局指标
主要结局
Change from baseline in insulin sensitivity (M value)
时间窗: Baseline, 3 months
Insulin sensitivity will be measured with the hyperinsulinemic euglycemic clamp technique and expressed as M value, calculated from the glucose infusion rate during the last 30 min of the clamp.
次要结局
- Change from baseline in oral glucose tolerance(Baseline, 3 months)
- Change from baseline in body composition(Baseline, 3 months)
- Change from baseline in phosphocalcic metabolism(Baseline, 3 months)
- Change from baseline in anthropometric parameters(Baseline, 3 months)
- Change form baseline in systolic and diastolic blood pressure(Baseline, 3 months)
- Change from baseline in inflammatory markers(Baseline, 3 months)
研究者
Giaccari Andrea
Associate Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS