NCT01007799已完成不适用
A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- score on the Sinonasal Outcome Test-22 (SNOT-22)
研究概览
简要总结
The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American (4 grandparents with AA ancestry)
- •Age>18 years
- •Diagnosis of chronic sinusitis
排除标准
- •Women of childbearing potential not utilizing contraception
- •Subjects with contraindications to vitamin D therapy
- •History of nephrolithiasis, hypercalcemia, sarcoidosis, recent (3 month) hospitalization
- •Use of immunosuppressants/medications that interfere with vitamin D metabolism (e.g., phenytoin and carbamazepine)
- •Malignancy
- •Kidney, gastrointestinal, or liver disorders
- •Immunodeficiency
- •Morbid obesity (BMI>35 kg/m2)
- •Changes to medications for 6 months prior to study entry
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo pills to take for 12 weeks
干预措施: vitamin D placebo (Dietary Supplement)
Vitamin D
Active Comparator
Vitamin D supplement for 12 weeks
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
score on the Sinonasal Outcome Test-22 (SNOT-22)
时间窗: study onset, mid-point and conclusion
次要结局
- Quality of life as measured by SF-36(At entry and at completion of study)
研究者
研究点 (1)
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