the Effect of Vitamin D in Crohn's Disease

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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 factors for recurrence after surgery for Crohn's disease and a serum 25(OH)D concentration <75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100-125 nmol/L.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing University School of Medicine
• Collaborator: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Clinical diagnosis of Crohn's Disease

2. Must be able to swallow tablets

3. 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 Criteria:

1. Other serious gastrointestinal diseases

2. pregnancy

3. hypercalcemia

4. hyperparathyroidism

5. chronic kidney disease and cardiovascular disease