NCT02365259Unknown1 期
Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from Baseline in Serum Vitamin D at 4 and 8 weeks
研究概览
简要总结
The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on vitamin D production in persons with MS.
详细描述
Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with multiple sclerosis
排除标准
- •Inability to stand still in a stabilized fashion without risk of falling for up to 6 minutes
- •Known medical history of calcium disorder or knowledge of high calcium levels
- •Known medical history of hyper-parathyroidism
- •Current supplementation with oral vitamin D
- •Known allergy to vitamin D
- •History of cancer of any type including but not limited to skin cancer
- •Obesity defined as BMI > 30
- •Known history of fat malabsorption conditions (i.e., steatorrhea)
- •Current use of anti-epileptic medication
- •Current use of glucocorticoids
- •Fitzpatrick skin types I and VI using the Fitzpatrick skin type analysis
- •Recent use of tanning facilities
研究组 & 干预措施
Phototherapy
Experimental
This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks.
干预措施: Phototherapy (Device)
Shame phototherapy
Placebo Comparator
This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light.
干预措施: Phototherapy (Device)
结局指标
主要结局
Change from Baseline in Serum Vitamin D at 4 and 8 weeks
时间窗: 0, 4, and 8 weeks
Venous blood will be collected to quantify levels of circulating Vitamin D.
次要结局
- Change from Baseline in Cognitive Function at 4 and 8 weeks(0, 4, and 8 weeks)
- Change from Baseline in Mood State at 4 and 8 weeks(0, 4, and 8 weeks)
- Change from Baseline in Walking Speed at 4 and 8 weeks(0, 4, and 8 weeks)
研究者
研究点 (1)
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