A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions
研究概览
简要总结
Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels are less likely to undergo surgeries and have better control of their disease. We intend to study the effects of high dose vitamin D supplementation in patients with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses will have less hospitalizations, surgeries, steroid use.
详细描述
Subjects are randomized to low or high dose vitamin D, and outcomes including steroid prescriptions, CD-related hospitalizations, CD-related surgeries, and the modified Harvey-Bradshaw Index are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CD
- •Age >= 18 and <75
- •Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D < 30ng/ml)
排除标准
- •Corticosteroid use in the last 4 weeks
- •CD-related surgery in the last 6 months
- •CD-related hospitalization in the last 4 weeks
- •Pregnancy, intended pregnancy during the study period or nursing
- •Serum calcium >10.2 mg/dL
- •History of primary sclerosing cholangitis
- •History of undergoing an ileal pouch-anal anastomosis
- •Current active perianal disease
- •History of nephrolithiasis in the past 2 years
- •Anticipated change in therapy in the next 30 days (steroids, biologic initiation)
- •modified Harvey-Bradshaw Index of 10 or more
- •History of decreased renal function (glomerular filtration rate <30ml/min based on MDRD) or polycystic kidney disease
- •History of sarcoidosis
- •History of hyperparathyroidism
- •Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma
- •Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or primidone
- •Osteoporosis
研究组 & 干预措施
Low Dose Vitamin D
Patients will be given 400 IU cholecalciferol once daily for 30 days. <-THIS IS THE Active Comparator Intervention. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.
干预措施: Cholecalciferol 400 IU (Drug)
High Dose Vitamin D
Patients will be given cholecalciferol 10,000 IU daily for 30 days. <-THIS IS THE INTERVENTION. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.
干预措施: Cholecalciferol 10,000 IU (Drug)
结局指标
主要结局
Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions
时间窗: Day 180
Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
Hypercalcemia
时间窗: Day 180
Hypercalcemia is presented as number of participants with Calcium \>10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
Incidence of Nephrolithiasis
时间窗: Day 180
Incidence of nephrolithiasis associated with hypercalcemia (\>10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
次要结局
- Percent With Escalation of Therapy(Day 180)
- Quality of Life Measure Changes(Day 180)
- Crohn's Related Hospitalizations(Day 180)
- Steroid Prescription Given (Dichotomous 0/1)(Day 180)
- Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)(Day 180)
- Change in Modified Harvey-Bradshaw Index (HBI Without Examination)(Day 180)
- Change in C-reactive Protein(Day 180)
- Changes in Fecal Calprotectin(1 year)
- Change in Fatigue Measurements(Day 180)
- Participants With at Least One Crohn's Related Emergency Department (ED) Visit(Day 180)
研究者
Peter Higgins
Assistant Professor
University of Michigan