Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Improvement in 25-OH vitamin D level
研究概览
简要总结
This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000 International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's disease in remission.
详细描述
In patients with Crohn's disease in remission, the investigators hypothesized higher doses of vitamin D would more effectively improve 25-hydroxy(OH)-vitamin D levels and would be tolerated well without side effects of hypercalcemia. The investigators also wanted to explore whether higher doses could reduce the clinical relapse rate of patients with Crohn's disease in remission, and if higher doses of vitamin D3 could improve depression and anxiety symptoms. In order to determine if there is benefit from high-dose vitamin D3, the investigators designed a pilot randomized double-blind controlled trial comparing doses of oral vitamin D3 at 10,000 IU daily to 1000 IU daily.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a prior diagnosis of Crohn's disease in clinical remission for at least 28 days with a Harvey-Bradshaw index less than or equal to 4
- •All maintenance therapies for Crohn's disease will be required to be at stable dose for at least 3 months before randomization, with no systemic steroid therapy within 4 weeks.
- •Vitamin D supplements will be discontinued at least 6 weeks before randomization.
排除标准
- •Women of child bearing potential who are considering pregnancy during the study period, currently pregnant, or unwilling to use contraception to avoid pregnancy
- •Participants with renal insufficiency (serum creatinine greater than 150 umol/L), sarcoidosis, hyperparathyroidism, malignancy, or any other disorder that may lead to hypercalcemia
- •Patients with short-gut syndrome or a serum albumin less than 32 g/L
- •Concomitant therapy with thiazide diuretics, barbiturates, digitalis, or supplemental products containing vitamin D
结局指标
主要结局
Improvement in 25-OH vitamin D level
时间窗: One year
次要结局
- Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS))(One year)
- Clinical Remission (defined as Harvey-Bradshaw index <=4)(One year)
- Adverse events(One year)
- Improvement in C-reactive protein(One year)