Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Effect on circulating inflammatory markers
研究概览
简要总结
Obesity is an increasing health problem with numerous metabolic complications. Vitamin D deficiency is common in obesity, and in epidemiological studies vitamin D deficiency has been linked to metabolic complications, such as type 2 diabetes, insulin resistance and cardiovascular disease, as well as myopathy, osteoporosis and depression. In obesity, a low grade inflammation is present in the fat tissue, thereby releasing inflammatory molecules to the blood stream. In cell line studies as well as small clinical studies vitamin D has been shown to have the ability to reduce inflammation and cell growth.
In the present study the investigators wish to investigate the effect of vitamin D on fat-, muscle and bone metabolism. 30 healthy obese subjects will be treated with cholecalciferol 175 micrograms daily for 6 months and will be compared with 30 healthy obese subjects treated with placebo.
The investigators hypothesize that restoring vitamin D levels in vitamin D deficient obese subject will reduce inflammation and thereby reduce obesity-related complications.
The effect will be evaluated as follows:
- Levels of circulating inflammatory markers will be examined in blood samples collected prior to and after treatment.
- Effects on fat- and muscle metabolism will be evaluated in fat- and muscle samples taken before and after treatment.
- Effects on fat distribution will be evaluated by MRI scan before and after treatment.
- Effects on insulin sensitivity will be evaluated by hyperinsulinaemic euglycaemic clamp performed on a subgroup of subjects with impaired fasting glucose.
- Effects on bone marrow density will be evaluated by DEXA scans before and after treatment.
- Effects on quality of life and depression score will be evaluated by questionnaires used before and after treatment.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy obese (BMI 30 - 45 kg/m2)
- •25(OH) vitamin D < 50 nmol/l
排除标准
- •Diabetes,
- •Pregnancy or non-safe contraception,
- •Vitamin D treatment within 3 months,
- •Hypercalcaemia, renal failure,
- •Liver failure, non eligibility for MRI-scan,
- •Severe osteomalacia,
- •Allergy towards study drug
研究组 & 干预措施
cholecalciferol
干预措施: Cholecalciferol (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Effect on circulating inflammatory markers
时间窗: 6 months
次要结局
- change in fat distribution(6 months)
- change in insulin sensitivity(6 months)
- change in bone mineral density(6 months)
- change in quality of life(6 months)
- change in depression score(6 months)
- change in muscle function(6 months)
- change in fat- and muscle metabolism(6 months)