the Effect of Vitamin D in Crohn's Disease

Early Phase 1

• Conditions: Crohn Disease; Vitamin D Deficiency
• Interventions: Drug: Placebo oral capsule; Drug: Vitamin D

• Registration Number: NCT04134065
• Lead Sponsor: Nanjing University School of Medicine

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-18
• Last Update Submitted: 2019-10-18
• Study First Posted: 2019-10-21
• Last Update Posted: 2019-10-21
• Study Start: 2019-12-01
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo oral capsule	The physical properties such as appearance, size, color, dosage form, weight, taste and odor of placebo should be as much as possible as the test drug, but should not contain the Vitamin D (such as tablets containing lactose).
Vitamin D group	Vitamin D	Liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL)

Primary Outcome Measures

Name	Time	Method
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
C-reactive protein	up to one year	circulating inflammatory markers
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.