Effects of a Vitamin D (Cholecalciferol) Supplement on Body Composition, Blood Pressure, and Lipid and Diabetes Parameters in Overweight Patients Attending a Telemedically Guided Weight Loss Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Body Weight From Baseline to 12 Months
研究概览
简要总结
The purpose of the study is to investigate in overweight patients who are on a telemedically guided weight loss program the influence of a daily vitamin D supplement on
- weight loss and body composition,
- selected inflammation markers and biochemical parameters of lipid and glucose metabolism .
- selected clinical parameters such as blood pressure, heart rate
详细描述
Obese patients are known to have low levels of vitamin D metabolites. There is some evidence that vitamin D and/or dietary calcium may influence energy metabolism and body weight. We therefore perform a prospective controlled trial with 200 overweight (Body mass index 27-29.9 kg/m2) and obese subjects (Body mass index >= 30 kg/m2) who are on a telemedically guided weight loss program. Subjects randomly receive a daily vitamin D supplement or a placebo for 1 year. Participants have to send their body weight data to the study office weekly. In addition, a nutritionist at the study office has to be contacted weekly to receive further support concerning the weight loss program. Dietary records have to be completed monthly. Clinical parameters and blood samples are collected at baseline, and after 6 and 12 months. It is the aim of the study to investigate the vitamin D effects on weight loss and body composition. In addition, possible vitamin D effects on clinical and selected biochemical parameters should be assessed. These parameters include heart rate, blood pressure, inflammation markers, and parameters of lipid and glucose metablolism.
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
- 是
入选标准
- •Body mass index > 27 kg/m2
排除标准
- •pregnant and lactating women
- •vegetarians
- •patients with renal insufficiency (creatinine > 1.5 mg/dl)
- •History of renal stones and gallstones
- •patients with insulin dependent diabetes mellitus
- •parallel participation in another clinical study
- •missing informed consent
- •subjects with pacemaker implantation
结局指标
主要结局
Change in Body Weight From Baseline to 12 Months
时间窗: baseline, 12 months
次要结局
- Change in Calcitriol From Baseline to 12 Months(baseline, 12 months)
- Change in Parathyroid Hormone From Baseline to 12 Months(baseline, 12 months)
- Change in Fat Mass From Baseline to 12 Months(baseline, 12 months)
- Change in Triglycerides From Baseline to 12 Months(baseline, 12 months)
- Change in Hb A1c From Baseline to 12 Months(change from baseline to 12 months)
- Change in 25-hydroxyvitamin D From Baseline to 12 Months(baseline, 12 months)
- Change in LDL-cholsterol From Baseline to 12 Months(baseline, 12 months)
- Change in C-reactive Protein From Baseline to 12 Months(baseline, 12 months)
- Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months(baseline, 12 months)
- Change in Proinsulin From Baseline to 12 Months(baseline, 12 months)