Intranasal Retinoic Acid Treatment for Patients With Olfactory Loss: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Olfactory Tests.
研究概览
简要总结
About One to 2 percent of the North American population below the age of 65 years experience olfactory loss to a significant degree. It can result from advanced age, Post-infestious/inflammatory disorders, Obstructive disorders (e.g. nasal polyposis, tumors), posttraumatic (head trauma) and neurodegenerative disorders. Only a few studies have shown benefits of specific therapy for olfactory loss.
Vitamin has shown promise from both animal and human studies. However, none has studied the benefits of topical application of vitamin A. This study will be the first to examine this effect.
详细描述
- Purpose
To determine if there is an improvement in olfactory function following the use of intranasal Vitamin A in patients with post-inflammatory and/or post-traumatic olfactory loss. 2. Hypothesis
There a significant improvement in olfactory function in patients with olfactory loss using intranasal vitamin A when compared with patients with olfactory loss not using intranasal vitamin A
Null Hypothesis There is no significant improvement in olfactory function in patients with olfactory loss using intranasal vitamin A when compared with patients with olfactory loss not using intranasal vitamin A 3. Justification
To treat post inflammatory and post-traumatic olfactory loss, a few controlled studies have shown a positive effect of a specific therapy for olfactory loss, such as olfactory training (using repeated intensive stimulation of the olfactory system and the use of prednisone. Other drugs studied like Vitamin B and Zinc, have either been insufficiently studied or showed no significant effect on olfactory loss.
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
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 19 years and above diagnosed with loss of olfactory function, (with or without history of sinonasal surgery) currently receiving sinonasal-related care at the St Paul's Sinus Centre.
排除标准
- •Patients with Primary anosmia.
- •Patients with baseline olfactory test scores >30 using Sniffin sticks test.
- •Patients with sinonasal tumors
- •Patients with polyps or significant inflammation blocking access of medication to the olfactory cleft.
- •Patients allergic to topical Vitamin A
- •Cystic fibrosis or syndromic patients
- •Patients with autoimmune diseases that have sinus manifestations or affect sinus function
- •Patients with previous history of hypervitaminosis A
- •Patients with Neurological Disease (e.g. stroke history, Parkinson's disease)
- •Patients who are pregnant
研究组 & 干预措施
B: Vitamin A
Group B: This study group will receive Vitamin A in addition to their standard of care. They will not receive olfactory retraining.
干预措施: Vitamin A (Dietary Supplement)
A: Vitamin A and Olfactory Retraining
Group A: This study group will receive intranasal vitamin A at 10,000 I.U. per day and olfactory retraining using scented oils in addition to their standard of care.
干预措施: Vitamin A (Dietary Supplement)
C: Standard of Care
Group C: This study group will receive only standard of care .
结局指标
主要结局
Olfactory Tests.
时间窗: For each subject this test will take 30 minutes
These tests will be performed by same blinded assessor using the "Sniffin sticks" kit described above. The test is divided into three subtests including tests for olfactory thresholds (using phenyl ethyl alcohol), odor discrimination, and odor identification (TDI). The sum of the three scores reliably indicates the degree of olfactory function.
次要结局
- Sinus Mucosal Inflammation - Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS)(For each subject this test will take about 5 minutes.)
- Sinonasal Outcomes Test - 22 (SNOT-22)(For each subject this test will take between 5-10 minutes.)
- Questionnaire of Olfactory Disorders(For each subject this test will take about 10 minutes.)
研究者
Amin Javer
Director, St. Paul's Sinus Centre
St. Paul's Hospital, Canada