In this study we want to assess whether supplementation of vitamin D directs the T cell compartment towards a less pro-inflammatory direction, with promotion of Treg function.
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We assess primarily the effects of vitamin D suppletion on regulatory T cell
function.
Secondary outcome
Furthermore, we assess the effect of the intervention on the composition of the
T cell compartment, assess descriptively to which extent vitamin D levels in
the serum are elevated, and assess whether the participant experience
side-effects.
Background summary
A poor vitamin D status has been associated with an increased risk for
developing multiple sclerosis (MS), and a more active disease course of MS.
Although the exact disease-process is uncertain, the T cell compartment has
been shown to play a vital role in it. Auto-reactive Th1 and Th17 cellen
contribute in the CNS to inflammation, while regulating T cells (Tregs) are not
capable to suppress this pathogenic response. Remarkably, vitamin D treatment
inhibits in experimental research pro-inflammatory Th1 and Th17 development,
and promotes anti-inflammatory Th2 and treg development. In our previous study,
we showed that vitamin D levels in the serum of MS patients correlate
positively with the function of regulatory T cells.
Study objective
In this study we want to assess whether supplementation of vitamin D directs
the T cell compartment towards a less pro-inflammatory direction, with
promotion of Treg function.
Study design
This is a cohort-study with 1 research arm in an open-label design.
Intervention
Patients have to take 500ug vitamine D3 solution a day for a period of 12
weeks.
Study burden and risks
Patients have to take the vitamin D solution every day and have to visit the
hospital 6 times for a venepuncture. An elevation of serum calcium levels
(hypercalcemia) has occasionally been described in patients supplemented with
high doses of vitamin D. A severe hypercalcemia can give rise to complications
as heart- and kidney faillure. However, the amount of vitamin D that we
supplement, de frequency of monitoring and the exclusion of potential highrisk
groups reduce this risk significantly.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28286.096.09 |
| Other | Onder het registratienummer van het huidig onderzoeksdossier |