Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04578470
Status:
UNKNOWN
Last Update Posted:
2020-10-09
First Post:
2020-10-05
Brief Title:
Benign Paroxysmal Positional Vertigo BPPV in Older Patients
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
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:
Benign Paroxysmal Positional Vertigo BPPV is the most common cause of vertigo in older adults Parham Kuchel 2016 It is caused by dislodged otoconia which fall from the utricular macula into the semicircular canals causing them to move through the canals with the effect of gravity Parnes et al 2003 Treatment of BPPV is primarily with Canalith Repositioning Procedure CRP with more than 80 success rates However BPPV can recur in 10-20 of the time and in some long-term follow-up studies reporting up to 50 recurrence rates Fife et al 2008 Despite BPPV being considered a benign self-limiting condition it has far reaching physical and psychosocial consequences for the geriatric population such as injuries from falls precipitated by vertiginous attacks and fear of unexpected vertigo leading to restriction of daily activities and functional decline Balatsouras et al 2018 Kao et al 2009 Studies have shown that the 1-year prevalence of individuals with BPPV attacks rises steeply with age with the cumulative lifetime incidence of BPPV reaching almost 10 by the age of 80 Parham Kuchel 2016 Aging has also been shown to be a primary risk factor for idiopathic BPPV with events such as prolonged bed rest postulated for being a trigger for BPPV Parham Kuchel 2016 BPPV is also noted to be underreported in the elderly mainly due to the different manifestations such as less rotatory vertigo and more nonspecific dizziness and instability with consecutive examinations in geriatric population revealing that 9 of elderly have unrecognized BPPV Oghalai et al 2000 Given the increased prevalence and severe implications of BPPV on there is a strong impetus for this study to lower the recurrence of BPPV in this vulnerable older population
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 patients 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 cholecalciferol1 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 30ngml 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 30ngml 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 Dietitians 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 patients 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 patients 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
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 cholecalciferol1 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 30ngml 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 30ngml 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 Dietitians 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 patients 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 patients 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 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