Multiple SclerosisEDSSNCT07123337
Serum 25-Hydroxyvitamin D and Neurological Disability in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University of Zintan at 1 site in Libya.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 369 participants
- Where
- 1 siteLibya
- Study dates
- 1 Aug 2023to 8 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Libyan male and females between 18 to 70 years diagnosed as MS
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Libya1 site
Faculty of medicine zintan university
Tripoli, Tripoli, 218
About this study
Official title: Serum 25-Hydroxyvitamin D and Neurological Disability in Multiple Sclerosis: A Cross-Sectional Study From the Mediterranean Epidemiological Frontier
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.
- Conditions
- Multiple Sclerosis
- Keywords
- EDSS, MS
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
EDSS
interaction between levels of Vit D and EDSS
Measured: 24 months
Serum 25-Hydroxyvitamin D
levels of Vit D
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Aug 2023
- Primary completion15 Feb 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zintan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123337
- Sponsor's protocol ID
- ZFM/2023/MS-01
- Acronym
- EDSS
- Status last verified
- Apr 2025
- First submitted
- 7 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36418179Gill 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.
PubMed 39364460Hanaei 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.
PubMed 34211673
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum 25-Hydroxyvitamin D and Neurological Disability in Multiple Sclerosis: A Cross-Sectional Study From the Mediterranean Epidemiological Frontier
- ClinicalTrials.gov ID
- NCT07123337
- Acronym / sponsor ID
- EDSS / ZFM/2023/MS-01
- Conditions
- Multiple Sclerosis
- Keywords
- EDSS, MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- University of ZintanUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Libyan male and females between 18 to 70 years diagnosed as MS
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EDSS
Time frame: 24 months
interaction between levels of Vit D and EDSS
Serum 25-Hydroxyvitamin D
Time frame: 24 months
levels of Vit D
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Results publication: PubMed 36418179Vasileiou 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.
- Results publication: PubMed 39364460Gill 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.
- Results publication: PubMed 34211673Hanaei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Zintan at 1 site in Libya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Libya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDSS (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07123337, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.