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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Page 1 of 1 (2 locations)

1

National Rehabilitation Center EKA

Nea Liosia, Athens, Greece, 13122

2

National Rehabilitation Center EKA (Ethniko Kentro Apokatastasis)

Athens, Attica, Greece, 13122