NCT01339676Unknown4 期
Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months
研究概览
简要总结
This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4 pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 55 years
- •remitting-relapsing multiple sclerosis according to McDonald criteria who fulfill the reimbursement criteria for interferon-beta and have used interferon-beta-1b for at least one month
- •EDSS (expanded disability statsu scale) ≤ 5
- •no neutralising antibodies to INFB as measured by indirect MxA test
- •prepared and considered to follow the protocol
- •using appropriate contraceptive methods (women of childbearing potential)
- •has given informed consent
排除标准
- •serum calcium >2.6 mmol/L
- •serum 25(OH)D2 (kalsidiol) > 85 nmol/L
- •presence of primary hyperparathyroidism (serum intact PTH, parathyroid hormone)>65 ng/L)
- •pregnancy or unwillingness to use contraception
- •alcohol or drug abuse
- •use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
- •current use of other immunomodulatory therapy than interferon-beta-1b
- •known allergy to cholecalciferol or arachis oil (peanuts)
- •therapy with digitalis, calcitonin or active vitamin D3 analogues during the previous 12 months or multivitamins containing vitamin D during previous two weeks preceding study entry
- •any condition predisposing to hypercalcaemia (such as any type of cancer)
- •sarcoidosis
- •nephrolithiasis or renal insufficiency, serum creatinine above 1.5 times the normal upper reference limit
- •significant hypertension (Blood Pressure <180/110 mmHg)
- •hyperthyroidism, or hypothyroidism in the year before the study began
- •a history of nephrolithiasis during the previous five years
- •cardiac insufficiency or significant cardiac dysrhythmia
- •unstable or advanced ischaemic heart disease
- •has suffered a major depression
研究组 & 干预措施
1
Experimental
Once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D
干预措施: Colecalciferol (Drug)
2
Placebo Comparator
Identically appearing once weekly peroral capsules
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months
时间窗: one year
次要结局
- Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on Measure: T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation(one year)
研究者
研究点 (1)
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