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    Summary
    EudraCT Number:2012-004602-97
    Sponsor's Protocol Code Number:VITADEM
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-004602-97
    A.3Full title of the trial
    ?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial?
    ?Vitamina D como tratamiento adyuvante para la esclerosis múltiple recurrente remitente: estudio unicéntrico, aleatorizado, doble ciego, controlado por placebo?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial?
    ?Vitamina D como tratamiento adyuvante para la esclerosis múltiple recurrente remitente: estudio unicéntrico, aleatorizado, doble ciego, controlado por placebo?
    A.3.2Name or abbreviated title of the trial where available
    VITADEM
    VITADEM
    A.4.1Sponsor's protocol code numberVITADEM
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJavier Olascoaga Urtaza
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDepartamento de Sanidad - Gobierno Vasco
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Donostia - Instituto Biodonostia
    B.5.2Functional name of contact pointAna Belen Asensio
    B.5.3 Address:
    B.5.3.1Street AddressPº Dr Beguiristain s/n
    B.5.3.2Town/ citySan Sebastian
    B.5.3.3Post code20014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034943006288
    B.5.5Fax number0034943006250
    B.5.6E-mailanabelen.asensiohuerga@osakidetza.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA
    D.2.1.1.2Name of the Marketing Authorisation holderKERN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLECALCIFEROL
    D.3.9.3Other descriptive nameCOLECALCIFEROL CONCENTRATE (OILY FORM)
    D.3.9.4EV Substance CodeSUB20705
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral drops, solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    RELAPSING-REMITING MULTIPLE SCLEROSIS
    ESCLEROSIS MULTIPLE RECURRENTE REMITENTE
    E.1.1.1Medical condition in easily understood language
    RELAPSING-REMITING MULTIPLE SCLEROSIS
    ESCLEROSIS MULTIPLE RECURRENTE REMITENTE
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Estudiar la eficacia de la vitamina D3 versus placebo en el curso clínico y radiológico de pacientes con esclerosis múltiple recurrente-remitente tratados con fármacos de primera línea, mediante el análisis de la proporción de pacientes que experimentan un brote a lo largo del estudio.
    E.2.2Secondary objectives of the trial
    1. To study the effect of vitamin D treatment on the relapse rate
    2. Evaluate the impact of vitamin D on the disability progression, measured by the EDSS.
    3. To study whether vitamin D reduces the number of gadolinium-enhancing lesions on brain MRI scans.
    4. To analyze whether vitamin D can prevent the appearance of new T2 hyperintense lesions on brain MRI scans.
    5. To study the safety and tolerability of vitamin D as adjuvant treatment, evaluating the presence of adverse events en this population.
    1. Estudiar el efecto del tratamiento con vitamina D sobre la tasa de brotes.
    2. Valorar si la vitamina D3 modifica progresión de la discapacidad medida por el EDSS.
    3. Analizar si la administración de vitamina D3 reduce el número de lesiones captantes de gadolinio en la RMN craneal.
    4. Estudiar si el tratamiento con vitamina D3 previene la aparición de lesiones nuevas hiperintensas en T2 en la resonancia craneal.
    5. Comprobar el grado de seguridad y tolerabilidad de la vitamina D3 como tratamiento adyuvante a los tratamientos de primera línea, evaluada por la presencia de efectos secundarios, en esta población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    - Pacientes deben aceptar y firmar el consentimiento informado
    - Pacientes de entre 18 y 65 años (inclusive)
    - Diagnosticados de esclerosis múltiple recurrente-remitente por criterios de Poser, McDonald o MAGNIMS según tiempo de evolución de la enfermedad.
    - Pacientes en tratamiento con fármacos de primera línea para el tratamiento de la EM (interferón beta o acetato de glatiramero) durante al menos 6 meses.
    - EDSS ?5.5 en el momento de la inclusión.
    - En caso de mujeres en edad fértil, deben de aceptar el uso de medidas anticonceptivas durante el estudio.
    E.4Principal 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.
    - Historia de alergia a la vitamina D
    - Pacientes en tratamiento inmunosupresor para la esclerosis múltiple
    - Hipercalcemia
    - Hiperparatiroidismo
    - Historia de enfermedad renal o hepática (con valores de ALS o AST > 2.5 del límite superior).
    - Embarazo o lactancia
    - Tratamiento concomitante con digitálicos, diuréticos (hidroclorotiazida, clorotiazida, clortalidona, indapamida y metolazona), fármacos antiepilépticos, colestiramina y colestipol.
    - Depresión mayor.
    - Hiper o hipotiroidismo
    - Enfermedad cardíaca, arritmia
    - Epilepsia activa en tratamiento con fármacos antiepilépticos
    - Historia de abuso enólico o de drogas
    E.5 End points
    E.5.1Primary end point(s)
    Main outcome: proportion of patients experiencing at least one relapse during the study period.
    Proporción de pacientes que sufren al menos un brote durante el tiempo de estudio. Un brote se define como el desarrollo de síntomas nuevos o recurrentes que afectan al sistema nervioso central y duran al menos 24 horas, después de un período de al menos 30 días de estabilidad clínica, y que no ocurre en un contexto de fiebre o infección.
    E.5.1.1Timepoint(s) of evaluation of this end point
    EVERY VISIT
    EN CADA VISITA
    E.5.2Secondary end point(s)
    - La tasa de brotes (número de brotes por unidad de tiempo)
    - EDSS. El EDSS (Expanded Disability Status Scale) se trata de una escala de valoración de la discapacidad del paciente. Se basa en la evaluación de sistemas funcionales (visual, piramidal, sensitivo, tronco-encéfalo, vejiga/intestino, mental, cerebelo y la capacidad de deambular) en conjunto y puntúa de 0 a 10, siendo 0 el paciente totalmente ambulante sin discapacidad y 10 el fallecimiento producido por EM (Anexo 2).
    - Número de lesiones captantes de gadolinio en la resonancia craneal
    - Número de lesiones nuevas hiperintensas en T2 en la resonancia craneal
    - Incidencia de efectos secundarios en pacientes tratados con vitamina D y placebo. Se registrarán los efectos secundarios más frecuentemente asociados con vitamina D (mareos, cefalea, vómitos, anorexia, diarrea, dolor abdominal, litiasis renal, más arriba sección de riesgos) y cualquier otra enfermedad intercurrente durante el estudio. Se considerarán efectos adversos graves los que requieran hospitalización, moderados los que requieran suspensión del tratamiento en estudio, y leves los que sean transitorios o no obliguen a suspender la medicación.
    - La tasa de brotes (número de brotes por unidad de tiempo)
    - EDSS. El EDSS (Expanded Disability Status Scale) se trata de una escala de valoración de la discapacidad del paciente. Se basa en la evaluación de sistemas funcionales (visual, piramidal, sensitivo, tronco-encéfalo, vejiga/intestino, mental, cerebelo y la capacidad de deambular) en conjunto y puntúa de 0 a 10, siendo 0 el paciente totalmente ambulante sin discapacidad y 10 el fallecimiento producido por EM (Anexo 2).
    - Número de lesiones captantes de gadolinio en la resonancia craneal
    - Número de lesiones nuevas hiperintensas en T2 en la resonancia craneal
    - Incidencia de efectos secundarios en pacientes tratados con vitamina D y placebo. Se registrarán los efectos secundarios más frecuentemente asociados con vitamina D (mareos, cefalea, vómitos, anorexia, diarrea, dolor abdominal, litiasis renal, más arriba sección de riesgos) y cualquier otra enfermedad intercurrente durante el estudio. Se considerarán efectos adversos graves los que requieran hospitalización, moderados los que requieran suspensión del tratamiento en estudio, y leves los que sean transitorios o no obliguen a suspender la medicación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    EVERY VISIT
    EN CADA VISITA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    ADJUVANT TREATMENT
    TRATAMIENTO ADYUVANTE
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last visit of the last subject (LVLS)
    ULTIMA VISITA DEL ULTIMO SUJETO RECLUTADO
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients at the end of their particiàtion in the trial, will continue their usual treatment.
    Los pacientes, al finalizar su participación en el ensayo, continuarán con su tratamiento habitual.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
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