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临床试验/NCT04578470
NCT04578470Unknown2 期

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

Changi General Hospital0 个研究点目标入组 60 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
60
主要终点
Reduce the recurrence rate of BPPV

研究概览

简要总结

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.

详细描述

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.

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
Double (Participant, Investigator)

盲法说明

The patient will also undertake a vitamin D and corrected calcium test. Based on the blood test results, the randomisation process and administration of Vitamin D treatment or placebo will be administered by unblinded team while the clinicians and the patients will remain blinded and will not be informed of their allocation within the study.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

研究组 & 干预措施

Group A

Experimental

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.

干预措施: Vitamin D (Drug)

Group B

Placebo Comparator

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.

干预措施: Placebo (Drug)

结局指标

主要结局

Reduce the recurrence rate of BPPV

时间窗: 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.

Delay time to onset of recurrent episodes of BPPV

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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