Effect of Omega-3 Supplementation in Patients With Smell Dysfunction Following Endoscopic Pituitary Tumor Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Change in Olfactory Function over 6-month post-op period
研究概览
简要总结
Omega-3 supplementation has been shown to have neuroprotective and potentially anti-inflammatory properties in both central and peripheral nerve injuries. The investigators are studying to see if omega-3 supplementation will affect olfactory (smell) function in patients with olfactory dysfunction following endoscopic removal of pituitary tumors.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sellar/parasellar tumor scheduled to undergo endoscopic transnasal transsphenoidal resection
- •18 years of age or older
- •English speaking
排除标准
- •Currently using blood thinning agents (aside from NSAIDs or cardioprotective ASA)
- •elevated AST, ALT, or alk phos >10% outside of normal range, if randomized to omega-3 group
- •diabetes, if randomized to omega-3 group and not already on omega-3 prescribed by another provider
- •unable to provide informed consent due cognitive deficiencies
研究组 & 干预措施
Control Group
Omega-3 Supplementation Group
Omega-3 supplementation
干预措施: Omega-3 (Dietary Supplement)
结局指标
主要结局
Change in Olfactory Function over 6-month post-op period
时间窗: Baseline (pre-tumor resection), at 6 months (post-tumor resection)
The University of Pennsylvania Smell Identification Test (UPSIT) will be used to determine baseline olfactory function prior to sellar/parasellar tumor resection for all subjects.The test consists of a total of 40 "scratch and sniff" strips which the individual must select the correct odor from four choices. The test is scored out of 40 items. The number of correct answers regarding the smells being experienced is the subject's score. The higher the score the better the sense of smell. A change in UPSIT scores of 10% or greater indicates a clinically significant improvement.
Difference in Olfactory Function at baseline, based upon tumor type (i.e. functional vs. non-functional tumor)
时间窗: Baseline (pre-tumor resection)
The University of Pennsylvania Smell Identification Test (UPSIT) will be used to determine baseline olfactory function prior to sellar/parasellar tumor resection for all subjects.The test consists of a total of 40 "scratch and sniff" strips which the individual must select the correct odor from four choices. The test is scored out of 40 items. The number of correct answers regarding the smells being experienced is the subject's score. The higher the score the better the sense of smell.
次要结局
未报告次要终点
研究者
Zara M. Patel
Assistant Professor
Stanford University