the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- C-reactive protein
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Crohn's Disease
- •Must be able to swallow tablets
- •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.
排除标准
- •Other serious gastrointestinal diseases
- •hypercalcemia
- •hyperparathyroidism
- •chronic kidney disease and cardiovascular disease
研究组 & 干预措施
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).
干预措施: Placebo oral capsule (Drug)
Vitamin D group
Liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL)
干预措施: Vitamin D (Drug)
结局指标
主要结局
C-reactive protein
时间窗: up to one year
circulating inflammatory markers
Discomportant complaint
时间窗: up to one year
Incidence of Treatment Adverse Events
24-hour urinary calcium
时间窗: up to one year
Determination of calcium in urine for 24 hours
Clinical disease activity
时间窗: up to one year
CDAI score
Fecal calprotectin
时间窗: 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.
次要结局
未报告次要终点
研究者
Lei Zheng
Clinical Professor
Nanjing University School of Medicine