A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Serum calcium
研究概览
简要总结
Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.
This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically definite MS
- •Age 18-55
- •EDSS 0-6.5
排除标准
- •EDSS => 7.0
- •Current Vitamin D3 use >4000 IU/d
- •Baseline (25(OH)D) level <20 mmol/L (frank deficiency) and >150 mmol/L
- •Pregnancy or inability/unwillingness to use contraception
- •History of cardiac arrhythmia
- •History of renal disease and nephrolithiasis
- •History of granulomatous disease or lymphoma
- •Relapse activity or steroid use in the past 60 days
结局指标
主要结局
Serum calcium
时间窗: at each dose change
次要结局
- Serum 25(OH)D(at each dose change)
- EDSS(at screening vs. end of trial)
- N-telopeptide (bone marker)
- ALP/AST/ALT(at each dose change)
- Creatinine/urea(at each dose change)
- EKG(at screening and end of trial)
- Renal ultrasound(at screening, mid-trial and end of trial)
- Cytokine profile/MMP/lymphocyte response assay
- Annualized relapse rate(year prior to trial versus year of trial)
- PTH(at each dose change)