Status:
UNKNOWN
the Effect of Vitamin D in Crohn's Disease
Lead Sponsor:
Nanjing University School of Medicine
Collaborating Sponsors:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Vitamin D Deficiency
Crohn Disease
Eligibility:
All Genders
20-60 years
Phase:
EARLY_PHASE1
Brief Summary
To evaluate the efficacy and safety of 12-week goal-directed therapy in the treatment of refractory inflammatory patients, and to initially explore treatment options. Patients with potential risk fact...
Detailed Description
The patients received oral liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL). A target 25(OH)D o...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Crohn's Disease
- Must be able to swallow tablets
- Have certain factors increase the risk of surgery in CD. include:
- current smoking
- fistulizing and stricturing disease behaviour
- early steroid use (medical need for steroids for treatment of first flare)
- disease in the end of the small bowel (i.e. ileum)
- disease in the middle part of the small bowel (i.e. jejunum), and
- young age at the time of the diagnosis.
Exclusion
- Other serious gastrointestinal diseases
- pregnancy
- hypercalcemia
- hyperparathyroidism
- chronic kidney disease and cardiovascular disease
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04134065
Start Date
December 1 2019
End Date
December 31 2020
Last Update
October 21 2019
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