25(OH)-Vitamin D and Its Association With Bone Density, Body Composition, Strength, Walking Speed, Physical Performance and Pain in Hospitalized Individuals With Neurological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of Participants with neurological disease and low levels of vitamin D
研究概览
简要总结
The NeuroVitD study aims to assess vitamin D levels in hospitalized cohorts with neurological disorders resulting in motor disabilities, providing epidemiological data necessary for guidelines. The primary objective is to assess vitamin D insufficiency in the neurological populations under investigation and secondary to evaluate the impact of vitamin D supplementation on problems associated with structural and functional parameters.
The NeuroVitD study will be a randomized, cluster, controlled intervention trial lasting 2 years, enrolling 120 individulas, (30 controls), including those with stroke, spinal cord injury, and traumatic brain injury. Comprehensive epidemiological data, including demographic and anthropometric information, will be documented alongside social behaviors such as exercise and smoking. Serum vitamin D levels, bone density, body composition, strength, speed, physical performance and pain will be assessed.
The study will also evaluate the effects of vitamin D supplementation at two distinct dosages: 50,000 I.U of vitamin D weekly for 8 weeks or 25,000 I.U of vitamin D for 4 weeks followed by 10,000 I.U of vitamin D drops weekly for an additional 4 weeks. Calcium, parathyroid hormone, and phosphorus levels will be assessed to examine the impact of vitamin D administration on additional biochemical markers.
The findings will encompass vitamin D levels, bone density, body composition, strength, walking speed, physical performance and pain. The impact of vitamin D supplementation on various biochemical parameters will be analyzed, along with gender and group comparisons. Correlations will be established based on participants' residential locations, the administration of vitamin D supplementation, seasonal variations, and associations with specific medications for neurological conditions.
详细描述
INTRODUCTION Vitamin D insufficiency in the context of neurodisability has been associated with an elevated risk of poor physical function, bone mineral density and fractures.Clinical experience indicates that the population in Greece generally exhibits lower levels of vitamin D compared to northern European populations. There is a lack of data in Greece concerning persons with neurological motor disorders, and globally, there are no established criteria for vitamin D recommendations.
PURPOSE To assess vitamin D levels in populations with neurological disorders that result in motor disabilities to provide the epidemiological data necessary for the guidelines.
The data from our study will establish a database for any future guidelines regarding vitamin D administration in neurological illnesses, which is now lacking.
The major objective of the study is to determine vitamin D insufficiency in the neurological populations under investigation, while the secondary objective is to assess the impact of vitamin D supplementation on structural and functional parameters.
METHOD The NeuroVitD trial will be a randomized, cluster-based, controlled intervention effectiveness trial of two years. Patient recruitment will occur from June 1, 2025, until June 1, 2027. A total of 120 individuals will participate, with 30 individuals designated as a control group. This includes strokes, spinal cord injuries, traumatic brain injuries, among others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •populations with neurological disorders
- •healthy volunteers (controls)
排除标准
- •The subject is excluded if they:
- •are legally or mentally incapable of comprehending and consenting to participate in the study
- •have a history of or exhibit indicators of metabolic bone disease, including the following: Hypoparathyroidism, primary hyperparathyroidism, recent hyperthyroidism (within the last six months), Paget's disease of bone;
- •grade 3 or 4 pressure ulcers present;
- •has undergone treatment with pharmacological agents influencing bone metabolism prior to the initial bone density assessment, including the following: bisphosphonates in the year prior to the bone density assessment ; parathyroid hormone in the year prior to the research ; estrogens, selective estrogen receptor modulators (SERMs), tibolone, or anabolic steroids within the preceding six months.
- •Thyroid drugs are permissible only if the dosage has remained consistent for the preceding six weeks and TSH levels are within the normal range.
- •Corticosteroid medication exceeding 7.5 mg of prednisone orally per day for a duration exceeding one month within the past six months.
- •Immunosuppressant therapy within the past year;
- •Vitamin A therapy above 10,000 IU per day or Vitamin D exceeding 5,000 IU per day.
- •Participants are prohibited from consuming additional vitamin D supplements exceeding 400 IU per day or traveling to regions with heightened sunshine exposure during the trial.
研究组 & 干预措施
controls
no intervention
vitamin D supplement 1
Deltius 50.000 i.u.
干预措施: DELTIUS (Dietary Supplement)
vitamin D supplement 2
Deltius 25.000 I.U. and Deltius 10000 I.U. drops
干预措施: DELTIUS (Dietary Supplement)
结局指标
主要结局
Number of Participants with neurological disease and low levels of vitamin D
时间窗: up to 12 months
Number of Participants with neurological diseases eg. stroke, spinal cord injury, traumatic brain injury and low levels of vitamin D
次要结局
- The number of participants with reduced structural and functional parameters due to vitamin D insufficiency and if these parameters are improved with supplements(up to 12 months)
研究者
Yannis Dionyssiotis
Head of 2nd Physical Medicine and Rehabilitation Department, National Rehabilitation Center EKA, Athens, Greece
Dionyssiotis, Yannis, M.D.