Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the numbers of vitamin D-responsive B cells after vitamin D administration.
研究概览
简要总结
Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Immune cells will be monitored from the blood over time.
详细描述
Vitamin D-deficient individuals will receive once
- double-blind, placebo controlled 100.000 I.U.vitamin D3
- intramuscular or subcutaneous
Blood will be taken over time and
- immune cells (T cells, B cells, myeloid antigen presenting cells) are characterized by flow-cytometry
- vitamin D-metabolites will be monitored
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •18-60 yrs
- •25-hydroxyvitamin D serum below 50 nmol/L
- •women only: effective contraception
排除标准
- •25-hydroxyvitamin D serum above 50 nmol/L
- •body-mass index <18 or >30 kg per m2
- •planned UV-exposure (UV-index > 5)
- •hypersensitivity to vitamin D
- •history of hypercalcemia, kidney stones, kidney insufficiency, sarcoidosis, pseudohyperparathyroidism concomitant vitamin A- and/or vitamin D treatment
- •treatment with immunosuppressants, immunomodulators, phenytoin, barbiturate, thiazide-diuretics, glycosides
- •immobile patients
- •out of normal range on screening visit (calcium,phosphate,creatinin,hematology)
- •psychiatric hospitalization
- •pregnancy / breast-feeding
- •dependency / relationship on sponsor
- •concomitant participation in other clinical trials (30 days before)
- •drug or alcohol abuse
- •lack of compliance
研究组 & 干预措施
subcutaneous 100.000 I.U. vitamin D3
subcutaneous 100.000 I.U. vitamin D3
干预措施: single administration of 100.000 I.U. vitamin D (Drug)
intramuscular 100.000 I.U. vitamin D3
intramuscular 100.000 I.U. vitamin D3
干预措施: single administration of 100.000 I.U. vitamin D (Drug)
intramuscular placebo
intramuscular 0.9% sodium chloride
干预措施: Placebo (Drug)
subcutaneous placebo
subcutaneous 0.9% sodium chloride
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the numbers of vitamin D-responsive B cells after vitamin D administration.
时间窗: up to 3 months
Peripheral B cells will be isolated before, after 1 week, 1 month and 3 months after vitamin D administration and characterized by flow-cytometry. Vitamin D-responsive B cells will be quantified before and 1 week, 1 month and 3 months after vitamin D administration.
次要结局
- Impact of vitamin D on specific humoral memory(up to 3 months)
- Characterize vitamin D-responding myeloid immune cells(up to 3 months)
- Vitamin D pharmacokinetics(up to 3 months)
- Characterize vitamin D-responsive T cells(up to 3 months)
研究者
Margitta Worm
Prof. Dr. med.
Charite University, Berlin, Germany