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

Completed

Conditions: MS
multiple sclerosis
10003816
10012303

Registration Number: NL-OMON36084

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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 <<=20 *g/d (800 IU/d);
- A serum 25-hydroxyvitamin D (25(OH)D) level available within 1 year prior to inclusion, being either <50 nmol/L OR >100 nmol/L.

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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