High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range
研究概览
简要总结
The goal of this study will be to assess the safety and efficacy of high-dose interval Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated with serial Remicade infusions.
详细描述
Study subjects will receiving 50,000 units of Vitamin D3 if they receive Remicade infusions every 4-6 weeks. Study subjects will receiving 100,000 units of Vitamin D3 if they receive Remicade infusions every 6-8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 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
- •Age 0-25 years
- •Measured serum level of 25-OH Vitamin D of 15-29 ng/ml in the last 8 weeks and no changes in Vitamin D supplementation in the interim
排除标准
- •Pregnant Women
- •History of underlying kidney disease
- •History of granulomatous disease
- •Inability to take oral Vitamin D
- •History of hypercalcemia or hypercalciuria
- •Currently taking an anti-epileptic medication
- •History of pre-existing liver disease (excluding primary sclerosing cholangitis, non-alcoholic fatty liver disease, or steatohepatitis)
研究组 & 干预措施
Vitamin D3 Treatment
Subjects receiving Remicade will be treated with oral Vitamin D3
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range
时间窗: Patients will continue to receive oral Vitamin D therapy for one year. We will be assessing the efficacy of oral Vitamin D therapy, in this dosing schema, to result in 25-OH Vitamin D levels during and at the conclusion of this one-year study.
The study will involve measuring serum 25-OH Vitamin D levels after the initiation of open-label therapy. This will be done approximately one month after starting therapy, at the end of the study interval (one year), and as clinically indicated over the course of the year. Serum 25-OH Vitamin D levels are the most robust metric for assessing Vitamin D sufficiency.
次要结局
- Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D(Patients will be monitored for urinary symptoms and complete serial urine assessments as outlined in the protocol. The impact of oral Vitamin D administration on calcium excretion will be evaluated during and at the conclusion of this one-year study.)
研究者
Web
Assistant Professor of Pediatrics
Boston Children's Hospital