EUCTR2013-000971-34-DK进行中（未招募）1 期
Mucosal immune regulation by high dose vitamin D treatment in Crohn’s disease - MirViDiC
Jørgen Agnholt0 个研究点目标入组 50 人开始时间: 2013年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •CD patients:
- •Age = 18 years and < 80 years
- •Negative pregnancy test (serum-HCG) for women of childbearing age before the start of the study. (Women not of childbearing age are defined as postmenopausal for at least 1 year or surgically sterilised (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)). Women of childbearing age included in the study will be required to use contraception during the entire study period (i.e. one of the following: contraceptive pills, intrauterine device, depot injection of gestagen, sub dermal implant, hormonal vaginal ring or transdermal patch). If contraceptive medicine is contraindicated the women must use condom for protection during the study period.
- •Known colon and/or ileoceacal Crohn’s disease according to established diagnostic criteria (clinical criteria plus endoscopic verification with colon- capsule endoscopy, and/or histology)
- •Active disease with HBI score > 5 and CRP > 8 or calprotectin > 100 mg/g
- •CDEIS score > 5
- •Healthy controls:
- •Age = 18 years and < 80 years
- •Negative pregnancy test (serum-HCG) for women of childbearing age before the start of the study. (Women not of childbearing age are defined as postmenopausal for at least 1 year or surgically sterilised (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)). Women of childbearing age included in the study will be required to use contraception during the entire study period (i.e. one of the following: contraceptive pills, intrauterine device, depot injection of gestagen, sub dermal implant, hormonal vaginal ring or transdermal patch). If contraceptive medicine is contraindicated the women must use condom for protection during the study period.
- •Serum 25-hydroxyvitamin D2+D3 < 60 nmol/l
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •CD patients:
- •Untreated infections, sepsis or opportunistic infections
- •25-hydroxyvitamin D2 + D3 > 100 nmol/l
- •Biological treatment with Infliximab or Adalimumab within 3 month
- •Unable to talk and understand Danish
- •Allergy to Dekristol, peanuts or soya
- •Allergy to Infliximab
- •Infliximab antibodies detected at previous Infliximab treatment
- •Active or suspicion of tuberculosis infection (positive T-spot, positive quantiferon gold-test or radiological changes on thoracic x-ray)
- •Active and chronic viral hepatitis, present CMV or EBV infection
- •Hypercalcaemia and/or hypercalcuria
- •Pseudohypoparathyrodism
- •Prior calcium-containing kidney stones
- •Disorders of renal calcium and phosphate excretion
- •Treatment with benzothiadiazine derivate, phenytoin, barbiturates or digoxin
- •Immobilisation
- •Sarcoidosis
- •Moderate to severe heart failure (NYHA class 3 and 4)
- •Present or former cancer
- •Breastfeeding
- •Demyelinating diseases inclusive Guillian-Barré and Multiple Sclerosis
- •Vaccination with living vaccine within 4 weeks
- •CD with untreated abscesses
- •Changes in azathioprine treatment dose within 3 months
- •Steroid dose > 20 mg/day (prednison) or > 3 mg/day budesonide
- •P-sodium > 150 mmol/l
- •P-chloride > 106 mmol/l
- •Over hydration
- •Healthy controls:
- •Hypercalcaemia or hypercalcuria
- •Ongoing infection
- •Known autoimmune disease
- •Allergy to Dekristol (cholecalciferol), peanuts or soya
- •Pseudohypoparathyrodism
- •Prior calcium-containing kidney stones
- •Disorders of renal calcium and phosphate excretion
- •Treatment with benzothiadiazine derivate, phenytoin, barbiturates or digoxin
- •Immobilisation
- •Sarcoidosis
- •Pregnancy or breast-feeding
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