NCT04849182

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

April 13, 2021

Last Update Submit

April 21, 2021

Conditions

Benign Paroxysmal Positional Vertigo (BPPV)

Keywords

BPPVVertistopVitamin DAlpha-lipoic acidZinc

Outcome Measures

Primary Outcomes (1)

  • Number of BPPV recurrences in patients supplemented with Vertistop D

    Change in the number of BPPV recurrences associated with the increase or normalization of Vitamin D serum levels after supplementation with Vertistop D

    0, 6 months

Secondary Outcomes (4)

  • Number of BPPV recurrences in patients supplemented with Vertistop-L

    0, 6 months

  • Mean difference in Dizziness Handicap Inventory (DHI) values

    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

Other Outcomes (1)

  • Incidence of adverse events

    2, 4, 6 months

Study Arms (3)

Vertistop D

ACTIVE COMPARATOR

Patients with deficiency (\<20 ng/mL, \<50 nmol/L) or insufficiency (20-30 ng/mL, 50-75 nmol/L) of Vitamin D

Dietary Supplement: Vertistop D

Vertistop L

ACTIVE COMPARATOR

Patients with normal vitamin D levels (\>30 ng/mL, \>75 nmol/L)

Dietary Supplement: Vertistop L

Control group

NO INTERVENTION

Patients meeting the inclusion criteria with normal levels of vitamin D (\>30 ng/mL, \>75 nmol/L)

Interventions

Vertistop DDIETARY_SUPPLEMENT

Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals

Vertistop D
Vertistop LDIETARY_SUPPLEMENT

Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)

Vertistop L

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 18 years of age;
  • Secondary BPPV;
  • Vitamin D levels greater than 100 ng/mL (\>250 nmol/L);
  • Pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policoro Hospital "Giovanni Paolo II"

Matera, 75100, Italy

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Executive

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 19, 2021

Study Start

December 4, 2018

Primary Completion

June 30, 2020

Study Completion

November 3, 2020

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations

IT(1)