NCT06791044Recruiting
25(OH)-Vitamin D and Its Association With Structural and Functional Parameters in Hospitalized Patients With Neurological Diseases
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 12 Jan 2025
- Start date
- 1 Sept 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Dionyssiotis, Yannis, M.D.
- Diseases
- Obesity, Osteoporosis
- NCT number
- NCT06791044
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Sept 2025 to the primary completion date, Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- populations with neurological disorders
- healthy volunteers (controls)
Age in the registry: 20 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Rehabilitation Center EKA (Ethniko Kentro Apokatastasis) Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| National Rehabilitation Center EKA Coordinator of this site? Confirm its status | Nea Liosia | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.