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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33514
Enrollment
15
Registered
2009-07-22
Start date
2009-10-14
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

Multiple Sclerosis

Interventions

Patients have to take 500ug vitamine D3 solution a day for a period of 12 weeks.

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Progressive MS phenotype - Relapse 1 time/week) - Alcohol or drug abuse - Pregnancy or the intention to become pregnant during the study period

Design outcomes

Primary

MeasureTime frame
We assess primarily the effects of vitamin D suppletion on regulatory T cell function.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)