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.
populations with neurological disorders
healthy volunteers (controls)
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.
Parallel
DELTIUS
Dietary supplementA treatment plan will be implemented, as applicable, consisting of 50,000 I.U of vitamin D weekly for 8 weeks
DELTIUS
Dietary supplementA treatment plan will be implemented, as applicable, consisting of 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 (totaling 8 weeks)
Number of Participants with neurological disease and low levels of vitamin D
Number of Participants with neurological diseases eg. stroke, spinal cord injury, traumatic brain injury and low levels of vitamin D
The number of participants with reduced structural and functional parameters due to vitamin D insufficiency and if these parameters are improved with supplements
The number of participants with reduced structural and functional parameters due to vitamin D insufficiency and if these parameters are improved with supplements, the impact of vitamin D supplementation on structural parameters eg. bone, body composition and functional parameters eg. muscle strength, walking speed, SPPB test, pain
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Dionyssiotis, Yannis, M.D.
Lead sponsor
Institute for Rehabilitation and Prevention of Disability Claudius Galenus N.G.O.
Collaborator
