Effect of a One Time Dose of Cholecalciferol on Serum Concentration of 25-Hydroxyvitamin D and Macrophages
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Primary Measure Assessing Change of Erythema and Edema
研究概览
简要总结
Optimal Vitamin D dosing to obtain adequate serum concentrations of 25-hydroxyvitamin D (25OHD) is controversial. The optimal dose and dosing interval is unknown, and the tendency over the last few years is to give higher, less frequent doses. Disease-specific dosing is of interest, and there may be optimal serum concentration targets based on disease process. The best evidence so far is for optimal bone health, where most experts agree that 25OHD serum concentration should be above 30 ng/ml.
There is mounting evidence that Vitamin D therapy will reduce inflammatory response and macrophage activation. The optimal dosing needed to decrease the inflammatory response is unclear, although our recent mouse model has demonstrated that a onetime high dose is effective. The investigators therefore hypothesize that a one-time high dose of cholecalciferol will be effective in suppression of macrophage production of tumor necrosis factor-alpha (TNFa) and inducible nitric oxide synthase (iNOS). The purpose of this pilot study is to assess the optimum dosage for the most macrophage suppression.
详细描述
3.4.1 Study Medication (Vitamin D/Placebo): Patients will be blocked randomized into one of four groups using a balanced assignment. The target number of patients is 20, with five patients who have successfully completed all assessments in each group. Groups will be closed to enrollment once their target is reached. The recruitment will continue until every group has reached its target. The investigative pharmacy will prepare each dosage according to the randomization and will hold the key to the dosing.
Participants and investigators will be blinded to those receiving cholecalciferol which comes in 50,000 I.U. dose capsules and those receiving a placebo. Participants will be randomized to 1 of 4 doses as outlined below. All participants will receive the same number of capsules. Five participants will be in each group and will be dosed according to the following dosing schema:
Table 1: Dosing Schema
Cholecalciferol Dosage Group
Control: 0 Cholecalciferol Capsules 4 Placebo Capsules
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ages 18 years or older
- •Fitzpatrick Skin Type I-Ill
- •In good general health and able to list all current medications and medical conditions
- •Capable of giving informed consent
排除标准
- •Volunteers ages 18 years or younger
- •Women who are pregnant, nursing, or who may become pregnant in the next 3 months
- •Participants taking illegal drugs
- •Chronic medical conditions
- •Currently taking statins, ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
- •Currently consuming 800 IU or more of vitamin D a day
- •Current or recent use of anti-inflammatory medications or any other medications that may cause photosensitivity, at the discretion of the Pl.
结局指标
主要结局
Primary Measure Assessing Change of Erythema and Edema
时间窗: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks
MED testing \& Recovery from UV-induced erythema and edema before a one time dose of cholecalciferol
次要结局
- Secondary Measure Assessing Change of Serum Vitamin D Levels and Skin Inflammation(Before:24 hours, 48 hours, 72 hours, 1 week, 2 weeks ; After: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month)
研究者
Kurt Lu
Assistant Professor
University Hospitals Cleveland Medical Center