Randomized, 3-arm Controlled Clinical Trial, Designed to Evaluate the Effectiveness of Supplementation With Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Number of BPPV recurrences in patients supplemented with Vertistop D
研究概览
简要总结
Randomized, 3-arm controlled clinical study, to evaluate the effectiveness of supplementation with Vertistop® D (food supplement containing alpha-lipoic acid at modified release, Carnosine and Zinc, Vitamin D and Vitamins B) and Vertistop® L (food supplement containing fast releasing alpha-lipoic acid, Carnosine, Zinc and Curcumin) in preventing recurrence of high-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
详细描述
Benign paroxysmal positional vertigo (BPPV) is the most common type of vertigo detectable in otoneurological clinical practice. It is characterized by violent, short and relapsing vertiginous crises that arise when the patient assumes certain positions of the head in the space and is accompanied by a usually "typical" paroxysmal positional nystagmus. In most cases we cannot trace the exact causal agent, so we mainly identify two forms: primitive forms and secondary forms. BPPV therapy is essentially physical, and it is based on specific maneuvers which make the otoconial mass come out of the semicircular canal. Recent studies showed the existence of a seasonal trend of BPPV related to fluctuations in Vitamin D levels. Based on these considerations this clinical trial was designed in order to evaluate the possible efficacy of the administration of Vitamin D (Vertistop® D) in preventing recurrence of BPPV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary BPPV;
- •Patients having BPPV of CSP or CSL (geo or apo, single or multi channel);
- •Patients with recurrent BPPV, defined as two or more episodes over the last six months, or three or more episodes in the last 12 months;
- •Informed consent.
排除标准
- •Patients under 18 years of age;
- •Secondary BPPV;
- •Vitamin D levels greater than 100 ng/mL (>250 nmol/L);
- •Pregnant or breastfeeding.
结局指标
主要结局
Number of BPPV recurrences in patients supplemented with Vertistop D
时间窗: 0, 6 months
Change in the number of BPPV recurrences associated with the increase or normalization of Vitamin D serum levels after supplementation with Vertistop D
次要结局
- Number of BPPV recurrences in patients supplemented with Vertistop-L(0, 6 months)
- Mean difference in the Visual Numeric Scale (VNS) values(0, 6 months)
- Mean difference in the Visual Analogue Scale (VAS) values(0, 6 months)
- Mean difference in Dizziness Handicap Inventory (DHI) values(0, 6 months)
研究者
Prof. Giacinto Asprella Libonati
Medical Executive
Azienda Sanitaria Locale di Matera