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临床试验/NCT03310242
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

Seoul National University Hospital0 个研究点目标入组 150 人开始时间: 2015年6月1日最近更新:
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)

研究者

申办方类型
Other
责任方
Sponsor

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