Actively Recruiting

Phase Not Applicable
Age: 20Years - 85Years
All Genders
Healthy Volunteers
ID06791044

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

Led by Dionyssiotis, Yannis, M.D. · Updated on 2025-06-08

120

Participants Needed

2

Research Sites

30 weeks

Total Duration

On this page

Sponsors

D

Dionyssiotis, Yannis, M.D.

Lead Sponsor

I

Institute for Rehabilitation and Prevention of Disability Claudius Galenus N.G.O.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

25(OH)-Vitamin D and Its Association With Structural and Functional Parameters in Hospitalized Patients With Neurological Diseases

Who Can Participate

Age: 20Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 20 to 85 years
  • Individuals with neurological disorders causing motor disabilities
  • Healthy volunteers (control group)
  • Ability to understand and consent to participate in the study
Not Eligible

You will not qualify if you...

  • Unable to comprehend or legally consent to the study
  • History or signs of metabolic bone diseases such as hypoparathyroidism, primary hyperparathyroidism, recent hyperthyroidism, or Paget's disease of bone
  • Presence of grade 3 or 4 pressure ulcers
  • Treatment with bone metabolism drugs (bisphosphonates, parathyroid hormone, estrogens, SERMs, tibolone, anabolic steroids) within specified recent timeframes
  • Unstable thyroid drug dosage or abnormal TSH levels
  • Use of corticosteroids over 7.5 mg prednisone daily for more than one month in the past six months
  • Immunosuppressant therapy within the past year
  • Vitamin A therapy above 10,000 IU/day or vitamin D exceeding 5,000 IU/day
  • Use of additional vitamin D supplements above 400 IU/day or travel to high sun exposure areas during the trial

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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)

Trial Site Locations

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

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Research Team

D

Dionyssiotis

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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