Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- vitamin D target
研究概览
简要总结
The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.
详细描述
The investigators will be administering oral high dose interval vitamin D3 concurrently when participants with inflammatory bowel disease (IBD) are receiving biologic therapy every 4-8 weeks. The investigators will collect additional bloodwork when participants are getting clinical labwork in order to assess markers of bone health and inflammation in response to vitamin D treatment. The investigators will serially assess with questionnaires associated measures, including dietary vitamin D and calcium intake, sunlight exposure, physical activity, fracture history, IBD disease activity, and overall health.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis
- •Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks
- •Age 5-25 years old, at study entry
- •Measured serum level of 25-OHD of less than 40 ng/mL in the last 4-8 weeks and no changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are evaluated routinely as part of standard clinical care for IBD
排除标准
- •History of any underlying kidney disease
- •History of preexisting liver disease
- •History of granulomatous disease
- •Inability to take oral vitamin D3 as a pill
- •History of hypercalcemia or hypercalciuria
- •Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix
结局指标
主要结局
vitamin D target
时间窗: at study conclusion, up to 64 weeks
assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL
次要结局
- urine safety parameter(at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion))
- vitamin D binding protein(at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion))
- parathyroid hormone(at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion))
- c-reactive protein(at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available)
- baseline questionnaire on overall health(at 0 weeks (entry into study))
- food frequency questionnaire(at 0 weeks (entry into study))
- bone mineral density(at study conclusion, up to 64 weeks, when clinically available)
- health-related quality of life questionnaire for inflammatory bowel disease(at 0 weeks (entry into study) and up to 64 weeks (at study conclusion))
- physical activity questionnaire(at 0 weeks (entry into study) and up to 64 weeks (at study conclusion))
- change in vitamin D level(at study conclusion, up to 64 weeks)
- serum safety parameter(at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion))
- cytokine measurements(at 0 weeks (entry into study) and up to 64 weeks (at study conclusion))
- follow-up questionnaire on overall health(at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks))
- markers of bone turnover(at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion))
- inflammatory bowel disease treatment parameters(at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion))
- fracture history questionnaire(at 0 weeks (entry into study))
- sun exposure questionnaire(at 0 weeks (entry into study) and up to 64 weeks (at study conclusion))
- erythrocyte sedimentation rate(at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available)
研究者
Rebecca Gordon
Attending Physician
Boston Children's Hospital