25(OH)-Vitamin D and Its Association With Structural and Functional Parameters in Hospitalized Patients With Neurological Diseases
Launched by DIONYSSIOTIS, YANNIS, M.D. · Jan 18, 2025
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
The NeuroVitD study is looking at the levels of vitamin D in hospitalized patients with neurological conditions, like strokes and spinal cord injuries, who may not have enough vitamin D. The main goal is to find out how common vitamin D deficiency is among these patients and to see if giving them vitamin D supplements can improve their physical abilities and overall health. The study will involve around 120 participants, including some healthy volunteers for comparison. Researchers will measure various health aspects, such as bone strength, body composition, walking speed, and pain levels, to understand the effects of vitamin D supplementation.
To be eligible for the study, participants must have a neurological disorder or be a healthy volunteer. However, certain individuals will not be able to participate, such as those with specific bone diseases or those taking certain medications that affect bone health. Over two years, participants can expect to receive vitamin D supplements at different doses and have their health monitored closely. This study aims to gather important information that could help improve health guidelines for people with neurological issues.
Gender
ALL
Eligibility 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.
About Dionyssiotis, Yannis, M.D.
Dr. Yannis Dionyssiotis, M.D., is a distinguished clinical trial sponsor specializing in innovative research and development within the medical field. With a focus on advancing therapeutic interventions and enhancing patient outcomes, Dr. Dionyssiotis leads rigorous clinical studies that adhere to the highest ethical and scientific standards. His extensive expertise encompasses various areas of medicine, enabling him to contribute valuable insights and foster collaboration among multidisciplinary teams. Committed to translating research findings into practical applications, Dr. Dionyssiotis is dedicated to driving progress in healthcare through evidence-based practices and cutting-edge clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ilion, Athens, Greece
Athens, Attica, Greece
Patients applied
Trial Officials
Yannis Dionyssiotis
Study Chair
National Rehabilitation Center EKA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported