- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04578470
Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients
A Double Blinded Randomized Control Trial (RCT) to Evaluate the Effectiveness of Vitamin D Treatment in Lowering the Recurrence Rate of Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study aims to investigate whether Vitamin D supplementation with diet, or diet alone combined with CRP (standard clinical care) can reduce recurrence of BPPV and if there is any improvement in the patient's functional ability, postural stability and prevalence of falls.
- Group A will be prescribed Vitamin D supplementation in the form of daily 2000 IU cholecalciferol (two tablets) for 13 weeks, and daily 1000 IU cholecalciferol(1 tablet) for another 13 weeks and then treatment will be discontinued but dietary interventions will continue.
- Group B will be prescribed placebo of Vitamin D with two tablets daily for 13 weeks then 1 tablet daily for 13 weeks then no treatment for 26 weeks but dietary interventions will continue.
- Group C will not receive any Vitamin D intervention for the entire 12- month study period but will receive dietary interventions.
The same day, patients will be grouped according to their Vitamin D status. Patients who are Vitamin D deplete (<30ng/ml) will be randomised into groups A or B.
Randomisation will be undertaken by the unblinded team, who will allocate randomly generated treatment using sealed opaque envelopes. The unblinded team will open the sealed envelope and the patient will be allocated to a group. The patient will not be informed of the treatment regime. Patients with replete Vitamin D levels (≥30ng/ml) will be serving as a control in group C. All clinical investigators will be blinded to the group assignments.
Unblinding can be undertaken for urgent clinical need, for example, fall with hip fracture requiring surgical intervention and high dose replacement of Vitamin D prior to initiation of bisphosphonate or other osteoporosis treatment.
All request for unblinding will be made to the unblinded team investigator to determine the need for unblinding prior to release of unblinded information. However, the dosing chosen for the study would permit the patient to have treatment with clinically needed high doses of vitamin D and continue on the study treatment without risk of hypervitaminosis D. The anonymous google survey undertaken indicated that some clinicians will use high dose replacement at the same time as maintenance dosing. Any cases that require unblinding will be discussed with the unblinded Investigator before the unblinding takes place but the outcome of the unblinding will not be communicated to the clinical team to allow the study assessments to continue.
All Groups (A, B, C) will receive dietary interventions across the 12- month study period and will be scheduled dietitian clinics to attend. Before their clinics, all patients will be issued instructions by the dietitian to record their dietary habits via a 3-day food record (3DFR- Appendix 4) and to send their 3DFR to the dietitian through mail or email, at least 5 days prior to their scheduled dietitian review. Patients will be provided a unique patient identification number in the study and will be asked to use this number in place of personal particulars when sending in their 3DFR. In the event that patients are unable to send in their 3DFR before their appointment, they will be asked to bring it on the day of the review itself.
1-2 weeks appointment All Groups (A, B, C) will be scheduled an ENT review in 1-2 weeks as routine clinical care for patients following CRP. Alongside this ENT review, they will also receive a referral to the dietitian clinic at this routine clinical visit for assessment of their dietary habits. ENT clinic will test all patients for efficacy of CRP treatment. Dietitian's clinic will provide assessment of patients' dietary habits from their 3DFR, provide counselling on dietary habits as well as take anthropometric measurements such as height, weight and BMI.
3rd month tele- consult All Groups (A, B, C) will receive a call from the audiologist who will check on BPPV recurrence with specific questions from the Shortened Dizziness Handicap Inventory Questionnaire (SDHIQ).
6th month appointment All Groups (A, B, C) will return for an audiologist review and dietitian review. At the audiologist review, patients will answer questions relating to BPPV recurrence, undergo Dix Hallpike test to check for recurrence of BPPV and balance and functional assessment in the form of Gans SOP, SPPB, BI and CFS. Patients from Group A and B will also be required to bring in their prescribed medications for a final pill count in order to check for compliance (performed by unblinded team). At the dietitian review, there will be assessment of the patient's dietary habits from their 3DFR (which is to be submitted 5 days prior to visit), counselling on dietary habits and taking of anthropometric measurements such as height, weight and BMI.
9th month tele- consult All Groups (A, B, C) will receive a call from the audiologist who will check on BPPV recurrence with specific questions from the SDHIQ.
12th month appointment All Groups (A, B, C) will return for the final audiologist review and dietician review. At the audiologist review, all patients will answer questions relating to BPPV recurrence and undertake a Dix Hallpike test to check for recurrence of BPPV. The audiologist will also administer balance and functional assessment in the form of Gans SOP, SPPB, BI and CFS for comparison with start of study. All groups will undertake a final serum vitamin D3 test and corrected calcium measurements. At the dietitian review, there will be assessment of the patient's dietary habits from their 3DFR (which is to be submitted 5 days prior to visit), counselling on dietary habits and taking of anthropometric measurements such as height, weight and BMI.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged >/=50 with a history suggestive of idiopathic BPPV, supported by a positive Dix Hallpike test. The study is to be undertaken in older patients hence the age criteria.
- Cognisant or mild neurocognitive impairment (AMT ≥7) to ensure the patient can provide informed consent.
- Both male and female participants will be recruited.
Exclusion Criteria:
- Patients with identified neurological causes of giddiness
- Patients with major neurocognitive impairment (severe dementia)
- Patients with sarcoidosis, metastatic disease (lymphoma, multiple myeloma), parathyroid disorders.
- Patients with diagnosed osteoporosis or osteopenia who are currently on high dose treatment (50,000 IU/week)
- Patients with significant cervical-spinal radiculopathy, spondylolisthesis, lordosis or kyphosis that will affect ability to carry out CRP
- Patients with disorders causing fat malabsorption (Short gut syndrome, Celiac disease) that will affect dietary absorption of Vitamin D
- Patients with Myasthenia Gravis
- Patients with unexplained hypercalcaemia
- Pregnant women (although this is extremely unlikely in age >/=50)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group C
Patients with replete VitaminD levels (≥30ng/ml) will be serving as a control in group C. Group C will not receive any Vitamin D intervention for the entire 12- month study period but will receive dietary interventions.
|
|
Experimental: Group A
Group A will be prescribed Vitamin D supplementation in the form of daily 2000 IU cholecalciferol (two tablets)for 13 weeks, and daily1000 IU cholecalciferol(1tablet) for another 13 weeks and then treatment will be discontinued but dietary interventions will continue across the 12-month study period.
|
Daily 2000 IU cholecalciferol(two tablets) for 13 weeks,and daily 1000 IUcholecalciferol(1 tablet) foranother 13 weeks.
|
Placebo Comparator: Group B
Group B will be prescribed placebo of Vitamin D with two tablets daily for 13 weeks then 1 tablet daily for13 weeks then no treatment for 26 weeks but dietary interventions will continue across the 12-month study period.
|
two tablets daily for 13weeks then 1 tablet daily for13 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduce the recurrence rate of BPPV
Time Frame: 2 Years
|
To determine if Vitamin D replacement in those deplete with Vitamin D, combined with dietary interventions, will reduce exacerbations of BPPV and thereby result in functional improvement.
|
2 Years
|
Delay time to onset of recurrent episodes of BPPV
Time Frame: 2 Years
|
To determine if Vitamin D replacement in those deplete with Vitamin D, combined with dietary interventions, will reduce exacerbations of BPPV and thereby result in functional improvement.
|
2 Years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Vestibular Diseases
- Sensation Disorders
- Vertigo
- Benign Paroxysmal Positional Vertigo
- Dizziness
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Vitamin D
Other Study ID Numbers
- BPPV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Paroxysmal Positional Vertigo
-
Chonbuk National UniversityUnknownBenign Paroxysmal Positional Vertigo (BPPV)Korea, Republic of
-
Riphah International UniversityCompletedBenign Paroxysmal Positional Vertigo (Disorder)Pakistan
-
Chiang Mai UniversityUnknown
-
Norfolk and Norwich University Hospitals NHS Foundation...Guy's and St Thomas' NHS Foundation Trust; University Hospitals, Leicester; University... and other collaboratorsRecruitingVestibular Migraine | Benign Paroxysmal Positional Vertigo (BPPV) | Ménière's DiseaseUnited Kingdom
-
Jordi Gol i Gurina FoundationPreventive Services and Health Promotion Research Network; Instituto de Salud... and other collaboratorsCompletedBenign Positional Paroxysmal VertigoSpain
-
Azienda Sanitaria Locale di MateraCompletedBenign Paroxysmal Positional Vertigo (BPPV)Italy
-
University of ZurichCompletedBenign Paroxysmal Positional VertigoSwitzerland
-
Xi'an No.3 HospitalRecruitingBenign Paroxysmal Positional VertigoChina
-
Dr. Mohammad Abu ShapheCompletedBenign Paroxysmal Positional VertigoSaudi Arabia
-
Aalborg University HospitalCompleted
Clinical Trials on Vitamin D
-
PfizerTerminated
-
Umeå UniversityRegion SkaneCompleted
-
Khon Kaen UniversityNot yet recruiting
-
Fundación Cardiovascular de ColombiaUniversidad Industrial de Santander; Farma de Colombia SACompletedVitamin D Deficiency | Overweight and Obesity | Overweight AdolescentsColombia
-
Nutrition Institute, SloveniaSlovenian Research Agency; Higher School of Applied Sciences (VIST); Valens Int...CompletedVitamin D DeficiencySlovenia
-
USDA, Western Human Nutrition Research CenterCompletedVitamin D DeficiencyUnited States
-
University of AarhusNot yet recruitingImmune System Diseases | Growth | Child Development | Vitamin D Supplementation
-
Cornell UniversityArogyavaram Medical CentreNot yet recruiting
-
University Hospital, Basel, SwitzerlandCompleted
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting