High dose vitamin D treatment in Crohn's disease affects the gut immune cells
- Conditions
- Active Crohn's Disease in colon and/or terminal ileumMedDRA version: 19.0 Level: LLT Classification code 10011408 Term: Crohns disease aggravated System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-000971-34-DK
- Lead Sponsor
- Jørgen Agnholt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method