Effects of Vitamin D Supplementation in Obesity
Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Aarhus、丹麦
- Dept. of Endocrinology and Metabolism, Aarhus University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy obese (BMI 30 - 45 kg/m2)
- 25(OH) vitamin D < 50 nmol/l
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较:安慰剂
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oral placebo tablets similar to active comparator
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有源比较器:cholecalciferol
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oral cholecalciferol tablets of 175 micrograms daily for 6 months
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Effect on circulating inflammatory markers
大体时间:6 months
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6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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change in fat distribution
大体时间:6 months
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6 months
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change in insulin sensitivity
大体时间:6 months
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6 months
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change in bone mineral density
大体时间:6 months
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6 months
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change in quality of life
大体时间:6 months
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6 months
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change in depression score
大体时间:6 months
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6 months
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change in muscle function
大体时间:6 months
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6 months
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change in fat- and muscle metabolism
大体时间:6 months
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6 months
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合作者和调查者
调查人员
- 首席研究员:Louise Wamberg, Dr.、Aarhus University Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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