The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in skin erythema
研究概览
简要总结
The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system.
An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown.
Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.
详细描述
Primary Endpoint To determine the effect of a topical application of Valchlor on human subjects at the clinically approved dose.
Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin irritation 48 hours after topical application of Valchlor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be in general good health
- •Fitzpatrick Skin Type I-VI
- •Able to list all current medications and medical conditions
- •Capable of giving informed consent
排除标准
- •Women who are pregnant, nursing, or who may become pregnant in the next 3 months
- •Participants taking illegal drugs
- •Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
- •Currently consuming 800IU or more of vitamin D a day
- •Subjects whose BMI are > 40
研究组 & 干预措施
Group 1: 4 placebo - 0 Vitamin D with Valchlor
Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
干预措施: 4 placebo (Dietary Supplement)
Group 1: 4 placebo - 0 Vitamin D with Valchlor
Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
干预措施: Valchlor (Drug)
Group 2: 0 placebo - 4 Vitamin D with mechloroethamine
Participants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor.
干预措施: 4 Vitamin D (Dietary Supplement)
Group 2: 0 placebo - 4 Vitamin D with mechloroethamine
Participants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor.
干预措施: Valchlor (Drug)
结局指标
主要结局
Change in skin erythema
时间窗: Up to 1 week after mechloroethamine exposure
Skin erythema (redness) will be quantified using a CR300 chromameter. The difference in erythema between exposed and non-exposed skin will be calculated after valchlor exposure
次要结局
- Change in skin thickness(Up to 1 week after mechloroethamine exposure)
- Change in TNF-alpha expression(Up to 120 hours after mechloroethamine exposure)
- Change in iNOS expression(Up to 120 hours after mechloroethamine exposure)
研究者
Kurt Lu
Assistant Professor
University Hospitals Cleveland Medical Center