Serum 25-Hydroxyvitamin D and Neurological Disability in Multiple Sclerosis

NCT ID: NCT07123337

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-04-08

Brief Summary

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Vitamin D is hypothesized to play a role in the immunopathology and progression of multiple sclerosis (MS), yet its association with neurological disability remains uncertain, particularly in North African populations.We conducted a cross-sectional study involving 369 adult MS patients across two tertiary neurology centers in Western Libya. Serum 25-hydroxyvitamin D \[25(OH)D\] levels and Expanded Disability Status Scale (EDSS) scores were collected. Pearson correlation, ANOVA, and multivariable linear regression were used to assess associations between vitamin D and disability, adjusting for age, BMI, disease duration, and physical activity. Missing data and outliers were handled systematically using validated R and Python workflows.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Libyan nationals.
* aged 18 years or older.
* diagnosis of MS based on the 2017 revised McDonald criteria.
* capable of providing informed consent.
* had complete clinical, demographic, and biochemical data.

Exclusion Criteria

* presence of other neurological disorders that could mimic MS (e.g., neuromyelitis optica spectrum disorder or Lyme disease).
* missing or incomplete medical records.
* pregnancy or lactation.
* extreme psychiatric or cognitive impairment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zintan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of medicine zintan university

Tripoli, Tripoli, Libya

Site Status

Countries

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Libya

References

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Vasileiou ES, Hu C, Bernstein CN, Lublin F, Wolinsky JS, Cutter GR, Sotirchos ES, Kowalec K, Salter A, Saidha S, Mowry EM, Calabresi PA, Marrie RA, Fitzgerald KC. Association of Vitamin D Polygenic Risk Scores and Disease Outcome in People With Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2022 Nov 23;10(1):e200062. doi: 10.1212/NXI.0000000000200062. Print 2023 Jan.

Reference Type BACKGROUND
PMID: 36418179 (View on PubMed)

Gill A, Orji C, Reghefaoui M, Peresuodei TS, Thota P, Saavedra Palacios MS, Arcia Franchini AP. The Effectiveness of Vitamin D Intake in Improving Symptoms and Relapses of Multiple Sclerosis: A Systematic Review. Cureus. 2024 Sep 3;16(9):e68565. doi: 10.7759/cureus.68565. eCollection 2024 Sep.

Reference Type BACKGROUND
PMID: 39364460 (View on PubMed)

Hanaei S, Sahraian MA, Mohammadifar M, Ramagopalan SV, Ghajarzadeh M. Effect of Vitamin D Supplements on Relapse Rate and Expanded Disability Status Scale (EDSS) in Multiple Sclerosis (MS): A Systematic Review and Meta-Analysis. Int J Prev Med. 2021 May 15;12:42. doi: 10.4103/ijpvm.IJPVM_208_20. eCollection 2021.

Reference Type BACKGROUND
PMID: 34211673 (View on PubMed)

Other Identifiers

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ZFM/2023/MS-01

Identifier Type: -

Identifier Source: org_study_id

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