Crohn Disease, Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Crohn Disease, recurrence
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 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.
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 of 100-125 nmol/L was planned and the dose titrated 4-weekly. Patients were evaluated at week 0 (screening visit), then 2- weekly until week 12, and at a follow-up visit at week 16. Key study endpoints were change in total 25(OH)D and attainment of level of 100e125 nmol/L. Intestinal inflammation was assessed via clinical disease activity (CDAI), faecal calprotectin (Calprotectin ELISA, Buhlmann, Basel, Switzerland), and circulating inflammatory markers (platelet count, serum albumin and C- reactive protein). Safety was assessed by direct questioning and 24- h urinary calcium excretion . Compliance was checked by dosing diaries completed by patients and measuring remaining cholecalciferol in bottles of the study drug. Statistical analyses were performed using SPSS v20 (IBM Corporation, 2011) and GraphPad Prism v5.04 (Graphpad software, 2010). Dependent and independent samples t-tests, analysis of variance (ANOVA) and KruskaleWallis tests were used where appropriate. Associations with rise in 25(OH)D were examined by bivariate correlations. A p-value of 0.05 was considered statistically significant.
Interventions
DRUGVitamin D
patients with refractory Crohn 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 100e125 nmol/L.
DRUGPlacebo oral capsule
the capsule contain nothing
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Nanjing University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical disease activity | up to one year | CDAI score |
| Fecal calprotectin | up to one year | Calprotectin is a calcium-containing protein derived from neutrophils and macrophages. Its expression is tissue or cell specific and can be used as a marker for activation of acute inflammatory cells. |
| C-reactive protein | up to one year | circulating inflammatory markers |
| Discomportant complaint | up to one year | Incidence of Treatment Adverse Events |
| 24-hour urinary calcium | up to one year | Determination of calcium in urine for 24 hours |
Contacts
Primary ContactLei Zheng, doctor
Backup ContactLei Zheng, doctor
Outcome results
None listed