Status:
RECRUITING
25(OH)-Vitamin D and Its Association With Structural and Functional Parameters in Hospitalized Patients With Neurological Diseases
Lead Sponsor:
Dionyssiotis, Yannis, M.D.
Collaborating Sponsors:
Institute for Rehabilitation and Prevention of Disability Claudius Galenus N.G.O.
Conditions:
Vitamin D Insufficiency
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief 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 pr...
Detailed Description
INTRODUCTION Vitamin D insufficiency in the context of neurodisability has been associated with an elevated risk of poor physical function, bone mineral density and fractures.Clinical experience indic...
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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06791044
Start Date
June 1 2025
End Date
December 31 2027
Last Update
June 8 2025
Active Locations (2)
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1
National Rehabilitation Center EKA
Nea Liosia, Athens, Greece, 13122
2
National Rehabilitation Center EKA (Ethniko Kentro Apokatastasis)
Athens, Attica, Greece, 13122