Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748249
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2023-02-10
Brief Title:
Evaluation of the Efficacy of Vertistop D and Vertistop L in the Prevention of BPPV Recurrence
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ngmL 75 nmolL 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 ngmL 50 nmolL or Vitamin D insufficient 20-30 ngmL 50-75 nmolL 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
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
Detailed Description:
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 25OH 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 enrollmentstart 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
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 enrollmentstart 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None