Vitamin D status and cognitive functioning in patients with relapsing remitting multiple sclerosis * a neuropsychological and functional MRI approach

Vitamin D status and cognitive functioning in patients with relapsing remitting multiple sclerosis * a neuropsychological and functional MRI approach - Vitamin D status and cognition in MS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36084

Enrollment

Registered

2011-08-04

Start date

2012-02-28

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS multiple sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - A definite, MRI-confirmed, RRMS (Polman et al., 2005); - A disease duration since the onset of first symptoms of *5 years; - An age of 18-50 years; - Treatment with either IFN-beta (Avonex, Betaferon, Rebif) or Glatiramer Acetate (Copaxone) or no disease modulating drugs (DMD) treatment; - No exacerbation within 6 weeks prior to assessment; - Vitamin D supplementation 100 nmol/L.

Exclusion criteria

Exclusion criteria: - Progressive disease without relapses; - Treatment with any immune suppressive or immune modulating drug or than IFN-beta or Glatiramer Acetate within 3 months prior to assessment; - Cognitive dysfunction reported by spouses, family or MS nurses, neurologist or reported by previous neuropsychological research - Presence of a depression as detected with the HADS (depression score *8; - Vitamin D supplementation more than 20 *g/d (800 IU/d); - Severe visual and/or verbal limitations interfering with neuropsychological testing; - Contraindications for MRI examination.

Design outcomes

Primary

Measure	Time frame
Psychometric assessments prior to MRI assessment: * Paced Auditory Serial Addition Test (PASAT) * Symbol Digit Modalities Test (SDMT) Functional MRI assessments: * Task related fMRI, using the Sternberg paradigm (working memory function) * Resting State fMRI, functional network integrity * DTI, structural network integrity * MR Spectroscopy, assessment of neurotransmitters GABA and glutamate Serum sampling for assessment of: * Vitamin D status (25(OH)D serum level) * Vitamin B12 status (Cobalamin serum level) - Cytokines in serum	—

Measure

Time frame

Psychometric assessments prior to MRI assessment: * Paced Auditory Serial Addition Test (PASAT) * Symbol Digit Modalities Test (SDMT) Functional MRI assessments: * Task related fMRI, using the Sternberg paradigm (working memory function) * Resting State fMRI, functional network integrity * DTI, structural network integrity * MR Spectroscopy, assessment of neurotransmitters GABA and glutamate Serum sampling for assessment of: * Vitamin D status (25(OH)D serum level) * Vitamin B12 status (Cobalamin serum level) - Cytokines in serum

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Secondary

Measure	Time frame
Psychometric assessments: -Fatigue will be measured with the Fatigue Severity Scale (FSS) -Depression will be measured with the depression-subscale of the hospital anxiety and depression scale (HADS) -Premorbid intelligence will be measured with the Nederlandse Leestest voor Volwassenen (NLV) Conventional MRI assessments: -T1-weighted images, for volumetric assessment (atrophy) -T2-weigthed FLAIR acquisition for lesion load assessment -Double Inversion Recovery (DIR), cortical lesion assessment	—

Measure

Time frame

Psychometric assessments: -Fatigue will be measured with the Fatigue Severity Scale (FSS) -Depression will be measured with the depression-subscale of the hospital anxiety and depression scale (HADS) -Premorbid intelligence will be measured with the Nederlandse Leestest voor Volwassenen (NLV) Conventional MRI assessments: -T1-weighted images, for volumetric assessment (atrophy) -T2-weigthed FLAIR acquisition for lesion load assessment -Double Inversion Recovery (DIR), cortical lesion assessment

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Countries

Netherlands

Outcome results