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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004602-97-ES

Enrollment

100

Registered

2012-11-12

Start date

2013-01-11

Completion date

Unknown

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RELAPSING-REMITING MULTIPLE SCLEROSIS MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA Pharmaceutical Form: Oral drops, solution INN or Proposed INN: COLECALCIFEROL Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 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.;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	—

Measure

Time frame

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 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.;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

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Secondary

Measure	Time frame
Secondary 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.;Timepoint(s) of evaluation of this end point: EVERY VISIT	—

Measure

Time frame

Secondary 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.;Timepoint(s) of evaluation of this end point: EVERY VISIT

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Countries

Spain

Contacts

Public ContactAna Belen Asensio

Hospital Donostia - Instituto Biodonostia

anabelen.asensiohuerga@osakidetza.net0034943006288

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026