"Randomized, Controlled 3-arm Clinical Study to Evaluate the Efficacy of Supplementation With Vertistop® D and Vertistop® L in Preventing Recurrences of Highly Recurring BPPV (Benign Paroxysmal Positional Vertigo)".
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in the number of BPPV recurrences in patients treated with Vertistop® D
研究概览
简要总结
The study involves the evaluation of 3 groups of subjects (3-arm study). Patients diagnosed with BPPV and "sufficient" serum concentrations of Vitamin D (>30 ng/mL, >75 nmol/L) at baseline may be treated with 2 tablets per day (morning and evening) of Vertistop® L ( Alpha-lipoic acid, carnosine, zinc and curcumin) or untreated, on the basis of the randomization criterion to which they will be assigned. Patients with Vitamin D "deficiency" (<20 ng/mL, <50 nmol/L) or Vitamin D "insufficient" (20-30 ng/mL, 50-75 nmol/L) at baseline, or subsequent follow-up, they will be treated for 2 months with Vertistop® D (alpha-lipoic acid, carnosine and zinc, vitamin D3 and vitamins of the B complex) taking 1 tablet a day (before meals).
The main purpose of the study is to evaluate, over a period of 6 months, the efficacy of Vertistop® D and Vertistop® L supplementation in preventing recurrences of BPPV (Benign Paroxysmal Positional Vertigo), in relation to blood levels of Vitamin D.
详细描述
Patients will be assigned to one of the three study groups following a randomization list with reference to groups 1 and 2 and according to the serum concentrations of 25(OH) Vitamin D, evaluated at the baseline visit, with reference to group 3.
The determination of the Vitamin D concentration will be requested by the Investigating physician and the report will be evaluated during the randomisation visit (V1), Visit 2, (after 2 months from enrollment/start of treatment), Visit 3 (Follow-up visit up to 4 months from enrollment) and finally Visit 4 (Follow-up visit 6 months after enrollment).
The blood sample and the Vitamin D dosage will be carried out the week before the day of the visit agreed with the Investigator, in a trusted laboratory of the patient, provided that it has the legal authorizations and the analytical methodology satisfactory the measurement intervals reported in Protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
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
- 是
入选标准
- •Patients of both sexes, aged between 18 and 85 years, diagnosed with primary BPPV.
- •Patients who have BPPV of the posterior semicircular canal (SPC) geo and apo, lateral semicircular canal (SLC) geo and apo (single-canal, multi-canal).
- •Patients with relapsing BPPV, defined as two or more episodes in the past six months, or three or more episodes in the last 12 months.
- •Patients able to understand and follow the requirements of the Study Protocol and to provide their informed consent.
排除标准
- •Patients under the age of
- •Secondary BPPV. Other causes of possible high recurrence BPPV and/or massive otolithic detachment:
- •Migraine;
- •Meniere's or delayed endolymphatic hydrops;
- •Lindsay Hemenway syndrome;
- •Otological and/or dental implant surgery in the last 3 months;
- •Conclusion within 30 days.
- •Patients with Vitamin D values exceeding 100 ng/mL (>250 nmol/L).
- •Pregnant or lactating women, as reported by the patient.
研究组 & 干预措施
First arm Vertistop® L.
BPPV patients will be assigned to the first arm have a "sufficient" serum concentration of Vitamin D between 31 and 100 ng/mL (76 and 250 nmol/L), which will be treated with Vertistop® L.
干预措施: Vertistop® D (Drug)
Third arm Vertistop® D
In the third arm, patients with serum values of Vitamin D "insufficient" i.e. between 20 and 30 ng/mL (50- 75 nmol/L) or "deficient" i.e. less than 20 ng/mL (50 nmol/L) which they will instead be treated with Vertistop® D.
干预措施: Vertistop® D (Drug)
结局指标
主要结局
Change in the number of BPPV recurrences in patients treated with Vertistop® D
时间窗: 6 months
Clinical Vestibular evaluation (presence of positional Nystagmus)
次要结局
- Increased normalization of Vitamin D(6 months)
研究者
Picciotti Pasqualina Maria
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS