Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels
Comparison of Sunlight Exposure and Oral Vitamin D Supplementation on Serum 25-hydroxyvitamin D Concentration and Metabolic Markers in Korean Young Adults: a Randomized Clinical Trial
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
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:
- Serum 25(OH)vitamin D < 12ng/mL
- age between 18 and 39 years
- Korean men and women
Exclusion Criteria:
- Vitamin D supplementation within 2 months
- Photosensitivity or UV allergy
- History of hyperparathyroidism/hypercalciuria/kidney stone/skin cancer and other cancer
- Under medication for hypertension, dyslipidemia, and diabetes
- Intake of photosensitive medicine during study period
- Exposure of strong UV (e.g., beach, sun tanning) during study period
- Pregnant/breast-feeding women
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sunlight Exposure
Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
|
|
|
实验性的：Vitamin D Supplementation
Supplementation of vitamin D3 500 IU/day for 8 weeks
|
- Supplementation of vitamin D3 500 IU/day for 8 weeks
|
|
安慰剂比较：Placebo
Intake of placebo for 8 weeks
|
- Intake of placebo for 8 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum 25(OH)D
大体时间：Baseline, 4 week, and 8 week
|
Changes in serum 25(OH)D levels in ng/mL
|
Baseline, 4 week, and 8 week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BMI
大体时间：Baseline, 4 week, and 8 week
|
Weight and height will be combined to report BMI in kg/m^2
|
Baseline, 4 week, and 8 week
|
|
Systolic blood pressure
大体时间：Baseline, 4 week, and 8 week
|
Systolic blood pressure changes in mmHg
|
Baseline, 4 week, and 8 week
|
|
Diastolic blood pressure
大体时间：Baseline, 4 week, and 8 week
|
Diastolic blood pressure changes in mmHg
|
Baseline, 4 week, and 8 week
|
|
Lipid panel
大体时间：Baseline and 8 week
|
Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL
|
Baseline and 8 week
|
|
Fasting glucose
大体时间：Baseline and 8 week
|
Serum fasting glucose in mg/dL
|
Baseline and 8 week
|
|
AST
大体时间：Baseline and 8 week
|
Serum AST levels in mg/dL
|
Baseline and 8 week
|
|
ALT
大体时间：Baseline and 8 week
|
Serum ALT levels in mg/dL
|
Baseline and 8 week
|
|
GGT
大体时间：Baseline and 8 week
|
Serum AST, ALT, and GGT levels in mg/dL
|
Baseline and 8 week
|
|
Intact PTH
大体时间：Baseline and 8 week
|
Serum intact PTH levels in mg/dL
|
Baseline and 8 week
|
|
Whole body BMD and BMC
大体时间：Baseline and 8 week
|
Whole body BMD (g/cm^2) and BMC (kg) measured by DEXA
|
Baseline and 8 week
|
|
Lean body mass, fat mass, and percent fat
大体时间：Baseline and 8 week
|
Lean body mass (kg), fat mass (kg), and percent fat (%) measured by DEXA
|
Baseline and 8 week
|
|
Lean body mass, muscle mass, skeletal muscle mass, fat mass, and percent fat
大体时间：Baseline, 4 week, and 8 week
|
Lean body mass (kg), muscle mass (kg), skeletal muscle mass (kg), fat mass (kg), and percent fat (%) measured by body impedance analysis
|
Baseline, 4 week, and 8 week
|
|
EQ-5D-5L
大体时间：Baseline, 4 week, and 8 week
|
Quality of life measured using EQ-5D-5L scale. The EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health status. In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale. The 5-level version of EQ-5D (EQ-5D-5L) was developed to improve such constraints of the three-level scale. EQ-5D-5L scale can define 3,125 (=5^5) different health states, and the 5-digit number can be converted into a preference weight which is also referred to as a single weighted index score. The index score of a value set derived from the general population sample can be regarded as a "societal valuation of the respondent's health state" in that country. |
Baseline, 4 week, and 8 week
|
合作者和调查者
调查人员
- 首席研究员：Hee-Kyung Joh, PhD、Seoul National University College of Medicine/Seoul National 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 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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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