"Rhinitis in the Elderly: A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study of the Effect of Vitamin D Supplementation on Nasal Symptoms and Rhinitis Related Quality of Life"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
研究概览
简要总结
A study of the role of vitamin D in elderly subjects with perennial and/or nonallergic rhinitis. The hypothesis is that vitamin D supplementation will improve rhinitis symptoms and rhinitis related quality of life.
详细描述
Rhinitis in the elderly is poorly understood as this group of patients has been ignored in almost all rhinitis studies. Vitamin D deficiency and insufficiency are very common, especially in the elderly. Vitamin D may play an important role in respiratory disease as shown by studies in asthma. This is a randomized, double-blind, placebo controlled, cross-over study. The investigators will look for the effect of vitamin D 4,000 I.U/day vs. placebo for six weeks on symptom scores and rhinitis related quality of life. This study will be performed in the period Nov. 1, 2013 and March 31, 2014, to try to avoid seasonal fluctuations of serum vitamin D due to sun exposure. The investigators will also look for possible associations between serum vitamin D at baseline and study subjects demographics, treatment, and symptom scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 65 years old and older with perennial and/or nonallergic rhinitis
排除标准
- •Current smokers, digoxin, liver disease, anticoagulants (except for aspirin), planning a surgical procedure during the study period.
研究组 & 干预措施
Vitamin D
Vitamin D 4,000 I.U. orally
干预措施: Vitamin D versus placebo (Dietary Supplement)
Placebo
Placebo orally
干预措施: Vitamin D versus placebo (Dietary Supplement)
结局指标
主要结局
Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
时间窗: 6 weeks
次要结局
- Associations between baseline serum vitamin D and subjects' demographics and treatment(6 weeks)
研究者
Michele Columbo, M.D.
Principal Investigator
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.