the Effect of Vitamin D in Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT04134065|
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Crohn Disease||Drug: Vitamin D Drug: Placebo oral capsule||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Placebo Comparator: Control group
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).
Drug: Placebo oral capsule
the capsule contain nothing
Other Name: Placebo
Experimental: Vitamin D group
Liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL)
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.
Other Name: VD
- Clinical disease activity [ Time Frame: up to one year ]CDAI score
- Fecal calprotectin [ Time Frame: 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 [ Time Frame: up to one year ]circulating inflammatory markers
- Discomportant complaint [ Time Frame: up to one year ]Incidence of Treatment Adverse Events
- 24-hour urinary calcium [ Time Frame: up to one year ]Determination of calcium in urine for 24 hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134065
|Contact: Lei Zheng, email@example.com|
|Contact: Lei Zheng, firstname.lastname@example.org|
|Study Chair:||Yousheng Li, Doctor||Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University|