the Effect of Vitamin D in Crohn's Disease

Nanjing University School of Medicine

Status and phase: Unknown; Early Phase 1

Conditions: Vitamin D Deficiency; Crohn Disease

Treatments: Drug: Vitamin D; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04134065

SJUSM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo oral capsule

Vitamin D group

Experimental group

Description:

Liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL)

Treatment:

Drug: Vitamin D