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

Javier Olascoaga Urtaza0 个研究点目标入组 100 人开始时间: 2012年11月12日最近更新: 2018年6月11日

适应症

试验速览

暂无简介。

•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

•-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.

发起方

Javier Olascoaga Urtaza