Actively Recruiting
25(OH)-Vitamin D and Its Association With Structural and Functional Parameters in Hospitalized Patients With Neurological Diseases
Led by Dionyssiotis, Yannis, M.D. · Updated on 2025-06-08
120
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
Sponsors
D
Dionyssiotis, Yannis, M.D.
Lead Sponsor
I
Institute for Rehabilitation and Prevention of Disability Claudius Galenus N.G.O.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
25(OH)-Vitamin D and Its Association With Structural and Functional Parameters in Hospitalized Patients With Neurological Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 to 85 years
- Individuals with neurological disorders resulting in motor disabilities
- Healthy volunteers as control group
You will not qualify if you...
- Unable to understand or consent to study participation
- History or signs of metabolic bone diseases such as hypoparathyroidism, primary hyperparathyroidism, recent hyperthyroidism, Paget's disease of bone
- Presence of grade 3 or 4 pressure ulcers
- Prior treatment affecting bone metabolism within specified timeframes, including bisphosphonates, parathyroid hormone, estrogens, SERMs, tibolone, or anabolic steroids
- Thyroid drug dosage not stable for six weeks or abnormal TSH levels
- Use of corticosteroids over 7.5 mg prednisone daily for more than one month in past six months
- Immunosuppressant therapy within the past year
- Vitamin A therapy above 10,000 IU daily or vitamin D above 5,000 IU daily
- Use of additional vitamin D supplements exceeding 400 IU daily or travel to high sun exposure areas during the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Rehabilitation Center EKA
Nea Liosia, Athens, Greece, 13122
Actively Recruiting
2
National Rehabilitation Center EKA (Ethniko Kentro Apokatastasis)
Athens, Attica, Greece, 13122
Actively Recruiting
Research Team
D
Dionyssiotis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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