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Vitamin D supplementation in patients with multiple sclerosis

Phase 1
Conditions
Relapsing remitting multiple sclerosis
MedDRA version: 20.1Level: LLTClassification code 10064137Term: Progression of multiple sclerosisSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Registration Number
EUCTR2017-004846-31-SI
Lead Sponsor
niversity medical centre Maribor
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
95
Inclusion Criteria

• Relapsing remitting MS
• Treatment with immunomodulatory drug
• Age 18-60 years and
• EDSS score less than 5.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of vitamin D supplements in the past 3 months
•Pregnancy, planing pregnancy or nursing
•Relapse of disease and corticosteroide use in past month
•Active inflammmation at the start of the study (flu, cystitis etc.)
•Renal disease
•Elevated levels od calcium or parathormone
•Hypersensitivity to vitamin D prepartions
•Switching of immunomodulatory drug in past 3 months
•Other autoimmune disease
•History of hyperparathyroidism, liver disease, tuberculosis, sarcoidosis or kidney stones

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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