NCT01369667已完成4 期
Vitamin D and Immunomodulation: Effects in Crohn's Disease
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.
研究概览
简要总结
The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All patients must fulfill the clinical criteria for diagnosis of Crohn's disease.
- •Subjects must have inactive CD as defined by CDAI < 150
- •CRP </=10 mg/L.
排除标准
- •Pregnant and lactating women.
- •Known hypersensitivity to vitamin D.
- •Hypercalcaemia
- •Current supplemental intake of vitamin D3 >800 IU/D.
- •Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma.
- •Participation in a concurrent clinical trial.
结局指标
主要结局
Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.
时间窗: 12 Months
次要结局
未报告次要终点
研究者
Tara Raftery
Research dietitian
University of Dublin, Trinity College
研究点 (1)
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