Vitamin D and Neurological Diseases: An Endocrine View.
Carolina Di Somma, Elisabetta Scarano, Luigi Barrea...
https://pubmed.ncbi.nlm.nih.gov/29160835Actively Recruiting
Led by Dionyssiotis, Yannis, M.D. · Updated on 2025-06-08
120
Participants Needed
2
Research Sites
30 weeks
Total Duration
D
Dionyssiotis, Yannis, M.D.
Lead Sponsor
I
Institute for Rehabilitation and Prevention of Disability Claudius Galenus N.G.O.
Collaborating Sponsor
Researchers are studying vitamin D levels in hospitalized individuals with neurological disorders that cause motor disabilities. The goal is to gather important data to help create guidelines for vitamin D use in these populations, including people with stroke, spinal cord injury, and traumatic brain injury. The study also aims to evaluate how vitamin D supplements affect bone density, body composition, strength, walking speed, physical performance, and pain. The study is a two-year randomized, controlled trial enrolling 120 participants, including 30 controls. Participants with low vitamin D levels will receive vitamin D supplements either as 50,000 I.U. weekly for 8 weeks or 25,000 I.U. for 4 weeks followed by 10,000 I.U. drops weekly for another 4 weeks. Controls have vitamin D levels above 20 ng/ml and do not receive supplementation. Measurements include serum vitamin D and related biochemical markers, assessed at the start and end of the study. Participants will undergo various assessments such as bone density scans using DXA, strength tests with a dynamometer, walking speed tests, physical performance evaluations with the SPPB test, and pain scoring. Demographic data and lifestyle factors like exercise and smoking will also be recorded. Safety and tolerance of vitamin D supplementation will be monitored. The primary outcome is the number of participants with neurological disease and low vitamin D levels, with secondary outcomes including improvements in structural and functional parameters due to supplementation.
CONDITIONS
25(OH)-Vitamin D and Its Association With Structural and Functional Parameters in Hospitalized Patients With Neurological Diseases
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants with low vitamin D levels receive vitamin D supplements for 8 weeks in one of two dosing plans. Control participants do not receive intervention. All participants continue usual rehabilitation care during the study.
Weekly visits for vitamin D supplementation during treatment
Duration - Up to 2 years
Participants have assessments at the beginning and end of the study, including vitamin D levels, bone density, body composition, strength, walking speed, physical performance, pain, and biochemical markers.
2 visits (at study start and end)
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
D
Dionyssiotis
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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