NCT03310242已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Serum 25(OH)D
研究概览
简要总结
This study aimed to compare the effects between sunlight exposure and oral vitamin D supplementation on serum 25-hydroxyvitamin D concentration and metabolic markers in Korean young adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Serum 25(OH)vitamin D < 12ng/mL
- •age between 18 and 39 years
- •Korean men and women
排除标准
- •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
研究组 & 干预措施
Sunlight Exposure
Experimental
Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
干预措施: Sunlight Exposure (Behavioral)
Placebo
Placebo Comparator
Intake of placebo for 8 weeks
干预措施: Placebo (Other)
Vitamin D Supplementation
Experimental
Supplementation of vitamin D3 500 IU/day for 8 weeks
干预措施: Vitamin D Supplementation (Dietary Supplement)
结局指标
主要结局
Serum 25(OH)D
时间窗: Baseline, 4 week, and 8 week
Changes in serum 25(OH)D levels in ng/mL
次要结局
- Lipid panel(Baseline and 8 week)
- Fasting glucose(Baseline and 8 week)
- BMI(Baseline, 4 week, and 8 week)
- Systolic blood pressure(Baseline, 4 week, and 8 week)
- Lean body mass, fat mass, and percent fat(Baseline and 8 week)
- Diastolic blood pressure(Baseline, 4 week, and 8 week)
- AST(Baseline and 8 week)
- ALT(Baseline and 8 week)
- GGT(Baseline and 8 week)
- Intact PTH(Baseline and 8 week)
- Whole body BMD and BMC(Baseline and 8 week)
- Lean body mass, muscle mass, skeletal muscle mass, fat mass, and percent fat(Baseline, 4 week, and 8 week)
- EQ-5D-5L(Baseline, 4 week, and 8 week)
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