Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in Mean Serum Level of 25-hydroxyvitamin D
研究概览
简要总结
This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or relevant gene expression response to oral vitamin D supplementation differs in patients with MS and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy or multiple sclerosis
- •Aged 18 to 60
- •Body mass index is between 18 kg/m2 and 30 kg/m2
- •Screening 25-hydroxyvitamin D level ≤ 75 nmol/L (30 ng/mL)
- •White race
- •Non-Hispanic ethnicity
- •Willing to use birth control during study
- •Willing to not use tanning bed during study
- •If subject has multiple sclerosis:
- •Relapsing-remitting MS, as defined by McDonald 2005 criteria
- •Screening Expanded Disability Status Scale score ≤ 3.0
- •Using no medication for MS, or taking Copaxone, (glatiramer acetate), interferons, or natalizumab
排除标准
- •Pregnant or nursing
- •Taking multivitamin & unwilling to remain off it during study
- •Taking cod liver oil & unwilling to remain off it during study
- •On a fat-restricted diet
- •History of renal disease or nephrolithiasis (kidney stones)
- •History of liver disease
- •Taking thiazide diuretics
- •History of hyperthyroidism
- •History of infection with Mycobacterium species
- •History of sarcoidosis
- •History of cancer
- •History of cardiac disease
- •History of HIV
- •History of gastrointestinal disorder
- •Taking medications that interfere with gastrointestinal absorption
- •Cigarette smoker in past month
- •Use of illicit drugs in past month
- •Use of steroids in past month
- •History of hypercalcemia, and screening serum calcium ≤ 10 mg/dL (UCSF) or ≤ 10.7 mg/dL (Johns Hopkins)
- •History of hypercalciuria
- •Evidence of anemia (Hgb <11.0 g/dL)
- •History of other serious medical conditions
- •Taking medications that involve the P450 system or may interact with vitamin D (digoxin, diltiazem, verapamil, cimetidine, heparin, or low-molecular weight heparin)
- •Other concerns about safety from the perspective of the treating physician
- •If subject has MS:
- •History of major heat sensitivity (leading to sun-avoidant behaviors)
研究组 & 干预措施
Vitamin D3
Both those with MS and healthy controls will be given vitamin D3 5000 IU/day by mouth for 90 days.
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change in Mean Serum Level of 25-hydroxyvitamin D
时间窗: Baseline to 90 days
Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.
次要结局
- Gene Expression Microarray(90 days)
- Change in Cytokine Levels(90 days)
- Change in Percentage of B Cells(90 days)
- Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)(Baseline, 90 days)