Efficacy of Vitamin D Supplementation in relapsing-remitting Multiple Sclerosis

Phase 1

• Conditions: Multiple Sclerosis and Clinical isolated Syndrome; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-002785-20-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-11
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Informed consent
Age between 18 and 65 at randomization
Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
EDSS = 6,0
Stable immunomodulatory treatment for at least 6 months
Sufficient birth control (Pearl-Index <1) and negative pregnancy test at screening/randomization

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 77
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Any other MS-course than RRMS
Treatment with vitamin D within three months prior to randomization
Any condition that could interfere with MRI or other study related investigation
Intolerability of Gd-DTPA
Hypercalcaemia and/or hypercalcuria
Presence or history of nephrolithiasis
Clinically relevant dysfunction of kidney (creatinine-clearance (Cockroft-Gault) Cl < 110ml/min (male) or Cl < 95ml/min (female)
Clinically relevant gastrointestinal, hepatological, pulmonary, cardiological, hematological, infectious or CNS-disease (other than MS) disease
Allergy against components of study drug
Treatment with hydrochlorthiazide, digitoxin, digoxin, phenytoin, barbiturates
Clinically relevant drug- or alcohol abuse
Pregnancy or lactation period
Participation in any clinical study within 3 months before or at any time during study
Treatment within 6 months before randomization with any other immunomodulatory substance than IFN-ß, glatiramer acetate or intravenous methylprednisolone
Any medical, psychiatric or other condition that could interfere with the patient’s ability to understand and give the informed consent, to comply with the protocol or to finish the study any ruling commitment or placement in an institution

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified