A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Vitamin D serum level Vitamin D sufficiency
研究概览
简要总结
Vitamin D repletion is important for bone health in patients with Crohn's disease. While repletion strategies in the general population yield similar results in those with Crohn's disease, maintenance strategies are variable. High quality evidence is lacking to determine the optimal strategy to maintain adequate levels of Vitamin D levels in patients with Crohn's disease.
详细描述
The investigators seek to identify patients with Crohn's disease in clinical remission who have vitamin D levels <30 ng/ml. Subjects will undergo a 8 week lead in period and receive Vitamin D supplementation with 50,000 IU D2 weekly for 8 weeks.Participants with sufficient Vitamin D levels after 8 weeks (>30 ng/mL) will be enrolled into the study and randomized to one of three arms: (1) placebo (2) 1000 IU/day Vitamin D3 (3) 5,000 IU/day Vitamin D3 for 22 weeks. Based on clinical experience, doses higher than the recommended doses for bone health in the general population (600-800 IU/day Vitamin D3) are needed to achieve and maintain optimal levels of Vitamin D in people with Crohn's disease.
The investigators aim to determine optimal maintenance dosing to sustain vitamin D sufficiency in people with Crohn's disease. The investigators also seek to determine demographic and disease related characteristics associated with inability to maintain sufficient levels.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Crohn's disease
- •In clinical remission as determined by the Harvey Bradshaw Index (CD) ≤4
- •25(OH)D level <30 ng/ml within three months of study enrollment
- •Prior 25(OH)D level <30 ng/ml currently on repletion therapy
- •Provided written informed consent
- •18 years of age or older
- •All maintenance therapies required to be on stable doses for 3 months.
排除标准
- •Unwilling to provide consent or lack capacity
- •Clinical disease activity (Harvey Bradshaw index >4)
- •Current pregnancy or attempting to conceive
- •Hypercalcemia (must have calcium level within 6 months of enrollment)
- •Known coexisting hyperparathyroidism
- •BMI >30 kg/m²
- •History of kidney stones
- •Subjects <18 years of age - pediatric population with different recommended dosing than adults
- •Non-english speakers
- •Has an ileo-anal pouch or ileostomy
- •C-reactive protein greater than 2x the upper limit of normal
- •Lactose intolerant
- •Short gut syndrome
- •Renal insufficiency (CrCl <60 ml/min)
- •Concomitant therapy with thiazide diuretics, barbiturates, digitalis or supplemental products containing vitamin D
- •Vitamin D levels <30ng/ml at completion of lead in
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Vitamin D 1000 IU D3 daily
干预措施: 1000 IU D3 (Dietary Supplement)
Vitamin D 5000 IU D3 daily
干预措施: 5000 IU D3 (Dietary Supplement)
结局指标
主要结局
Vitamin D serum level Vitamin D sufficiency
时间窗: 22 weeks
Serum level greater than or equal to 30 ng/ml
次要结局
- Time to Vitamin D Insufficiency(22 weeks)
研究者
Gil Melmed
Clinical Director of Inflammatory Bowel Disease
Cedars-Sinai Medical Center