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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 85
Healthy Volunteers: t
View:

• populations with neurological disorders

• healthy volunteers (controls)

Locations
Other Locations
Greece
National Rehabilitation Center EKA (Ethniko Kentro Apokatastasis)
RECRUITING
Athens
National Rehabilitation Center EKA
RECRUITING
Nea Liosia
Contact Information
Primary
Dionyssiotis
yannis_dionyssiotis@hotmail.com
00306946469759
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 120
Treatments
Active_comparator: vitamin D supplement 1
Deltius 50.000 i.u.
Active_comparator: vitamin D supplement 2
Deltius 25.000 I.U. and Deltius 10000 I.U. drops
No_intervention: controls
no intervention
Related Therapeutic Areas
Sponsors
Leads: Dionyssiotis, Yannis, M.D.
Collaborators: Institute for Rehabilitation and Prevention of Disability Claudius Galenus N.G.O.

This content was sourced from clinicaltrials.gov