The effects of vitamin D3 supplementation on the T cell compartment in Multiple Sclerosis; a pilot-study

Completed

Conditions: Multiple Sclerosis
MS
10012303

Registration Number: NL-OMON33514

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Relapsing Remitting MS (Revised McDonald criteria 2005)
- Disease duration since MS-onset <6 years
- At start of study >6 weeks in remission
- Use of Interferon Beta (1a or 1b) as immune modulation
- Age > 18 years

Exclusion Criteria

- Progressive MS phenotype
- Relapse <6 weeks before start study
- Abnormalities of vitamin D hormonal system other than low dietary intake or limited sun exposure (i.e. malabsorption, chirrosis, nephrotic syndrome, hyperthyreoidism, renal faillure, rickets, hypoparathyreoidism, kown malignancy, granulomatous disorders (tuberculosis, sarcoidosis, silicosis), and lymphomas).
- Intake of drugs that influence vitamin D homeostasis other than corticosteroids (i.e. Orlistat, anticonvulsants).
- Conditions with an increased susceptibility to hypercalcemia (known arrythmia or heart disease, treatment with digitalis or hydrochlorothiazide and those who suffer from nephrolithiasis).
- Frequent use of tanning beds (>1 time/week)
- Alcohol or drug abuse
- Pregnancy or the intention to become pregnant during the study period

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We assess primarily the effects of vitamin D suppletion on regulatory T cell<br /><br>function. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore, we assess the effect of the intervention on the composition of the<br /><br>T cell compartment, assess descriptively to which extent vitamin D levels in<br /><br>the serum are elevated, and assess whether the participant experience<br /><br>side-effects. </p><br>