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

NCT06791044 | Recruiting

• 1 other identifier: BFIAPEKA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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 primary objective is to assess vitamin D insufficiency in the neurological populations under investigation and secondary to evaluate the impact of vitamin D supplementation on problems associated with structural and functional parameters. The NeuroVitD study will be a randomized, cluster, controlled intervention trial lasting 2 years, enrolling 120 individulas, (30 controls), including those with stroke, spinal cord injury, and traumatic brain injury. Comprehensive epidemiological data, including demographic and anthropometric information, will be documented alongside social behaviors such as exercise and smoking. Serum vitamin D levels, bone density, body composition, strength, speed, physical performance and pain will be assessed. The study will also evaluate the effects of vitamin D supplementation at two distinct dosages: 50,000 I.U of vitamin D weekly for 8 weeks or 25,000 I.U of vitamin D for 4 weeks followed by 10,000 I.U of vitamin D drops weekly for an additional 4 weeks. Calcium, parathyroid hormone, and phosphorus levels will be assessed to examine the impact of vitamin D administration on additional biochemical markers. The findings will encompass vitamin D levels, bone density, body composition, strength, walking speed, physical performance and pain. The impact of vitamin D supplementation on various biochemical parameters will be analyzed, along with gender and group comparisons. Correlations will be established based on participants' residential locations, the administration of vitamin D supplementation, seasonal variations, and associations with specific medications for neurological conditions.

Conditions

Vitamin D Insufficiency

Keywords

25OHvitD; bone density; body composition; strength; pain; sarcopenia; osteoporosis; sarcopenic obesity; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Number of Participants with neurological disease and low levels of vitamin D

  Number of Participants with neurological diseases eg. stroke, spinal cord injury, traumatic brain injury and low levels of vitamin D

  up to 12 months

Secondary Outcomes (1)

• The number of participants with reduced structural and functional parameters due to vitamin D insufficiency and if these parameters are improved with supplements

  up to 12 months

Study Arms (3)

vitamin D supplement 1

ACTIVE COMPARATOR

Deltius 50.000 i.u.

Dietary Supplement: DELTIUS

vitamin D supplement 2

ACTIVE COMPARATOR

Deltius 25.000 I.U. and Deltius 10000 I.U. drops

Dietary Supplement: DELTIUS

controls

NO INTERVENTION

no intervention

Interventions

DELTIUS DIETARY_SUPPLEMENT

A treatment plan will be implemented, as applicable, consisting of 50,000 I.U of vitamin D weekly for 8 weeks

vitamin D supplement 1; vitamin D supplement 2

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• populations with neurological disorders
• healthy volunteers (controls)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dionyssiotis, Yannis, M.D.: lead
• Institute for Rehabilitation and Prevention of Disability Claudius Galenus N.G.O.: collaborator

Study Sites (2)

National Rehabilitation Center EKA

Nea Liosia, Athens, 13122, Greece

RECRUITING

National Rehabilitation Center EKA (Ethniko Kentro Apokatastasis)

Athens, Attica, 13122, Greece

RECRUITING

Related Publications (3)

• Di Somma C, Scarano E, Barrea L, Zhukouskaya VV, Savastano S, Mele C, Scacchi M, Aimaretti G, Colao A, Marzullo P. Vitamin D and Neurological Diseases: An Endocrine View. Int J Mol Sci. 2017 Nov 21;18(11):2482. doi: 10.3390/ijms18112482.

  PMID: 29160835 RESULT

• Moretti R, Morelli ME, Caruso P. Vitamin D in Neurological Diseases: A Rationale for a Pathogenic Impact. Int J Mol Sci. 2018 Jul 31;19(8):2245. doi: 10.3390/ijms19082245.

  PMID: 30065237 RESULT

• Kimball SM, Holick MF. Official recommendations for vitamin D through the life stages in developed countries. Eur J Clin Nutr. 2020 Nov;74(11):1514-1518. doi: 10.1038/s41430-020-00706-3. Epub 2020 Aug 20.

  PMID: 32820241 RESULT

MeSH Terms

Conditions

Pain; Sarcopenia; Osteoporosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yannis Dionyssiotis

  National Rehabilitation Center EKA

  STUDY CHAIR

Central Study Contacts

Dionyssiotis

CONTACT

00306946469759; yannis_dionyssiotis@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of 2nd Physical Medicine and Rehabilitation Department, National Rehabilitation Center EKA, Athens, Greece

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)