Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Expanded disability state scale score (EDSS)
研究概览
简要总结
Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial.
They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI:18-30kg/m2
- •caucasian race
- •Relapsing remitting multiple sclerosis
- •treatment with interferon beta
排除标准
- •Recent vitamin D supplement therapy
- •Restricted fat diet
- •nephrolithiasis in recent 5 years
- •Past history of hyperparathyroidism, sarcoidosis, cancer
- •Past history of hepatic disease
- •Past history of gastrointestinal disease
- •Past history of mycobacterial infection
- •Past history of hypercalcemia and hypercalciuria
- •serum creatinine>1.5
- •Smoking, drug abuse and corticosteroid therapy in recent year
- •treatment with thiazides or other drugs that inhibit vitamin D absorption
- •Disease attack in recent 2 months
- •Serum Ca>2.6mm0l/L
- •Serum 25(OH)D>85mmol/L
- •hypersensitivity to cholecalciferol
- •Past history of heart disease
- •Major depression
- •Uncontrolled hypertension (BP>180/110)
- •Immunosuppressive therapy
研究组 & 干预措施
Vitamin D
treatment with weekly 50000IU vitamin D
干预措施: Vitamin D (Drug)
Placebo
Treatment with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Expanded disability state scale score (EDSS)
时间窗: Changes in EDSS from baseline to 6 months
次要结局
- Annual relapse rate(ARR)(Changes in ARR from baseline to 12 months)
研究者
Mahmoud Abedini
associate professor of neurology
Mazandaran University of Medical Sciences