A One Year Prospective, Randomized, Double Blind Interventional Study to Assess Tolerability, Quality of Life and Immunomodulation With Interferon Beta Combined With Vitamin D in Patients With Relapsing Remitting Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions.
研究概览
简要总结
The investigators hypothesize that vitamin D supplementation may ameliorate interferon beta-induced flu-like symptoms, owing to reduced release and activity of the cytokines that are in correlation with this adverse event. Vitamin D supplementation may also positively affect injection site reactions due to its immunomodulatory effects. Vitamin D may also augment the therapeutic efficacy of interferon beta among multiple sclerosis (MS) patients. Vitamin D intake may influence melatonin levels of MS patients as they share the same nuclear receptor.
详细描述
Detailed Description of Study Evaluations
Adherence to treatment evaluation:
Patients will be asked to bring the empty packages of the IFN beta and Vitamin D that were used during the study.
Flu like symptoms and Injection site reactions evaluation:
Data regarding FLS and ISRs will be collected by means of a telephone interview every other week. The extent of FLS on the day of injection will be evaluated using a self-rating scale. A score from 0 (not at all) to 5 (very strong), will be given to each FLS component, i.e.: myalgia, chills, headache, malaise and fatigue, exacerbation of neurologic symptoms, sweating and difficulty to function compared to the time before injection. Patient will also record their oral temperature upon awakening as well as at their discretion. All patients will be provided with the same thermometer. Participants will be asked to report the frequency of Ibuprofen or Paracetamol use. and will be recommended not to exceed 800mg of Ibuprofen or 1000mg of Paracetamol per day, unless the symptoms are unbearable.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a diagnosis of RRMS according to the McDonald criteria (2005)
- •At least 18 years of age
- •Patients are treated with IFN-beta for RRMS. The decision to treat with IFN beta will be independent from this study protocol.
- •Patients will be either newly diagnosed, who are going to start IFN beta therapy for the first time or RRMS patients who suffer from FLS while being treated with IFN beta.
- •Insufficient blood levels of 25-hydroxy-vitamin D (below 75nmol/l according to current definitions.
- •EDSS score up to 7
- •Willing and able to give informed consent
排除标准
- •Patients having abnormalities of vitamin D related hormonal system other than low dietary intake or decreased sun exposure will be excluded. Namely, malabsorption [Celiac, Whipple, Inflammatory bowl disease, Intestinal bypass surgery, Short bowel syndrome, Cirrhosis, Nephrotic syndrome, Hyperthyroidism, Renal failure [creatinine clearance of less than 40 ml/min], Rickets, Hypoparathyroidism, Hypercalcemia at baseline, known malignancy, granulomatous disorders (Sarcoidosis, Tuberculosis, Silicosis) and Lymphomas.
- •Patients who take medications that influence vitamin D metabolism, other than corticosteroids, will be also excluded. Namely, Orlistat, Anticonvulsants [Phenobarbital, Primidone, Phenytoin], Rifampin, Isoniazide, ketoconazole, 5FU and Leucovorin
- •Patients with conditions with increased susceptibility to hypercalcemia will be excluded too: known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide.and those who suffer from nephrolithiasis.
- •Other Central Nervous System disorders than RRMS
- •Psychiatric disorders such as psychosis, bipolar disorder or substance abuse
- •Pregnancy
- •Contra-indication to treatment with IFN-beta
结局指标
主要结局
Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions.
时间窗: One year
次要结局
- Expanded Disability Status Scale (EDSS) progression(1 year)
- Relapse rate(1 year)
- Quality of life(1 year)
- Change in serum levels of cytokines and proteins involved in MS pathogenesis(12 months)
- Immune cells subsets(6 months)
- Night time Urine levels of 6-sulphatoxy-melatonin(1 year)
- Percent rise of IL6 and TRAIL levels following IFN-beta injection(3 months)