the Effect of Vitamin D in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04134065
• Other study ID #: SJUSM
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: Nanjing University School of Medicine
• Contact: Lei Zheng, doctor
• Phone: 86-13705270060
• Email: blanch_zll[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin 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.
• Placebo oral capsule
the capsule contain nothing

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing University School of Medicine	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

References & Publications (1)

Garg M, Rosella O, Rosella G, Wu Y, Lubel JS, Gibson PR. Evaluation of a 12-week targeted vitamin D supplementation regimen in patients with active inflammatory bowel disease. Clin Nutr. 2018 Aug;37(4):1375-1382. doi: 10.1016/j.clnu.2017.06.011. Epub 2017 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical disease activity	CDAI score	up to one year
Primary	Fecal calprotectin	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.	up to one year
Primary	C-reactive protein	circulating inflammatory markers	up to one year
Primary	Discomportant complaint	Incidence of Treatment Adverse Events	up to one year
Primary	24-hour urinary calcium	Determination of calcium in urine for 24 hours	up to one year