?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial?

Phase 1

Conditions: RELAPSING-REMITING MULTIPLE SCLEROSIS
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-004602-97-ES

Lead Sponsor: Javier Olascoaga Urtaza

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Written informed consent must be optained before any assessment is performed.
2.Male or female patients aged 18 to 65 years (inclusive), at the time of informed consent.
3.A documented diagnosis of relapsing-remiting MS (RRMS), according to the Poser, McDonald o MAGNIMS criteria, according to disease evolution time. (appendix 5)
4.Treatment with interferon-beta , glatimer acetate for a minimum 6 month prior to randomizacion.
5.EDSS score at baseline ? 5.5
6.Subjects of childbearing potential must practice effective contraception during the study.
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-History of allergy to vitamin D.
-Pacient in treatment with immunosuppressive medication for EM or second-line immunomodulators (fingolimod, human monoclonal anti-body)
-Known history of hypercalcemia
-Known history of hyperparathyroidism
-Known history of hyperthyroidism, hypothyroidism
-Known history of hepatitis or renal disease (ALS or AST > 2.5 of the upper limit )
-Femele subject who are pregnant or currently breastfeeding
-In treatment with digitals, diuretics (Hydrochlorothiazide (Microzide) Chlorothiazide, Indapamide, Metolazone (Zaroxolyn) ), antiepileptic therapy, cholestyramine, colestipol
-Known history of major depressión
-Significant cardiac disease, cardiac dysrhythmia (arrhythmia)
-Active epilepsy in treatment with antiepileptic therapy.
-History of drug or alcohol abuse.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of vitamin D3 versus placebo as an add-on treatment to the first-line disease modifying therapies for relapsing-remitting multiple sclerosis on the clinical activity, measured as the proportion of patients experiencing a relapse within the study period.;Secondary Objective: 1. To study the effect of vitamin D treatment on the relapse rate<br>2. Evaluate the impact of vitamin D on the disability progression, measured by the EDSS.<br>3. To study whether vitamin D reduces the number of gadolinium-enhancing lesions on brain MRI scans. <br>4. To analyze whether vitamin D can prevent the appearance of new T2 hyperintense lesions on brain MRI scans.<br>5. To study the safety and tolerability of vitamin D as adjuvant treatment, evaluating the presence of adverse events en this population.;Primary end point(s): Main outcome: proportion of patients experiencing at least one relapse during the study period.;Timepoint(s) of evaluation of this end point: EVERY VISIT

Secondary Outcome Measures