Vitamin D and its link to bone health, muscle strength, and pain in hospitalized neurological patients
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
This trial will test whether giving vitamin D to hospitalized adults with stroke, spinal cord injury, or traumatic brain injury helps bone density, body composition, strength, physical performance, and pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Dionyssiotis, Yannis, M.D. Indiv |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Nea Liosia, Athens and 1 other locations) |
| Trial ID | NCT06791044 on ClinicalTrials.gov |
What this trial studies
NeuroVitD is a two-year, randomized cluster-controlled intervention enrolling 120 participants (including 30 controls) hospitalized with neurological conditions that cause motor disability. Investigators will collect demographic and behavioral data and measure serum 25(OH) vitamin D, bone mineral density, body composition, muscle strength, speed, physical performance, and pain. A vitamin D supplementation protocol will be compared with control clusters to see if supplementation changes structural and functional outcomes. The trial aims to build an epidemiological database to inform future vitamin D guidance for neurodisabled populations in Greece.
Who should consider this trial
Good fit: Hospitalized adults with neurological disorders causing motor disability (for example stroke, spinal cord injury, or traumatic brain injury) who can give informed consent and do not have excluded metabolic bone diseases or recent bone-active treatments.
Not a fit: People with normal vitamin D status, active metabolic bone disease, recent treatment with bone-modifying drugs, or those unable to consent are unlikely to benefit from study supplementation.
Why it matters
Potential benefit: If successful, the trial could show that correcting vitamin D insufficiency improves bone health, muscle function, and pain control in people with neurological motor disabilities.
How similar studies have performed: Prior research links low vitamin D to worse bone and muscle outcomes and some trials show benefit from supplementation, but randomized data specifically in hospitalized neurodisabled populations are limited and results on functional gains have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * populations with neurological disorders * healthy volunteers (controls) Exclusion Criteria: * 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.
Where this trial is running
Nea Liosia, Athens and 1 other locations
- National Rehabilitation Center EKA — Nea Liosia, Athens, Greece (Recruiting)
- National Rehabilitation Center EKA (Ethniko Kentro Apokatastasis) — Athens, Attica, Greece (Recruiting)
Study contacts
- Study coordinator: Dionyssiotis
- Email: yannis_dionyssiotis@hotmail.com
- Phone: 00306946469759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.