The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach to the Effects of Vitamin D in Adipose Tissue and Peripheral Blood
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies
研究概览
简要总结
The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in adipose tissue will be studied in 50 subjects.
详细描述
Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with coronary heart disease, cancer and immunological diseases, and also with obesity, hypertension and glucose intolerance. However, to see the full effect of vitamin D, one should not only look at single diseases or risk factors, but have a global approach using a combined clinical index. A similar line of thinking can be applied to genetic, proteomic and metabolomic studies on vitamin D. Thus, in the present study 50 subjects will be included and randomized to vitamin D 40.000 IU per week versus placebo for 2 months. Blood and adipose tissue samples will be collected before and after the intervention and analyzed for gene expression. Based on these results the investigators will proceed with the relevant proteomic and metabolomic profile analyses. If successful, this may reveal new aspects of vitamin D's physiology and metabolic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •serum 25OHD in the range 20 - 40 nmol/L
- •no change in medication last 4 weeks
排除标准
- •women < 60 yrs of age (to avoid influence of menstrual cycle)
- •reduced kidney function
- •serious diseases (cardio-vascular, diabetes, etc)
- •taking vitamin d supplementation
研究组 & 干预措施
Placebo
two capsules (identical looking to the vitamin D capsules) will be given per week for two months
干预措施: Placebo (Drug)
Cholecalciferol
Vitamin d (as a 20.000 IU capsule) will be given i a dose of 40.000 IU per week for two months
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies
时间窗: 2 months
次要结局
- Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response(2 months)
- Change from baseline in proteomic profile with relative quantification in adipose tissue biopsies with the use of Liquid chromatography mass spectrometry Technology (LC-MS/MS)(2 months)
- Effect of VDR (vitamin D receptor) polymorphisms on change from baseline in proteomic profile with relative quantification in adipose tissue biopsies with the use of LC-MS/MS(2 months)
- Change from baseline in metabolomic profile with relative quantification in adipose tissue biopsies with the use of Liquid chromatography mass spectrometry Technology (LC-MS/MS)(2 months)
- Effect of VDR (vitamin D receptor) polymorphisms on change from baseline in metabolomic profile with relative quantification in adipose tissue biopsies with the use of LC-MS/MS(2 months)