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    Summary
    EudraCT Number:2022-002157-25
    Sponsor's Protocol Code Number:CIVI/2021/ET-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-09-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-002157-25
    A.3Full title of the trial
    Description des effets immunologiques périphériques d’un traitement vitamine D à forte dose chez les sujets sains. Essai randomisé monocentrique en double aveugle
    Description des effets immunologiques périphériques d’un traitement vitamine D à forte dose chez les sujets sains. Essai randomisé monocentrique en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Description des effets de la vitamine D chez les sujets sains
    Description des effets de la vitamine D chez les sujets sains
    A.3.2Name or abbreviated title of the trial where available
    VDSS
    VDSS
    A.4.1Sponsor's protocol code numberCIVI/2021/ET-01
    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 SponsorCHU de Nîmes
    B.1.3.4CountryFrance
    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 supportCHU de Nîmes
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nîmes
    B.5.2Functional name of contact pointBrigitte LAFONT
    B.5.3 Address:
    B.5.3.1Street AddressPlace du Professeur Debré
    B.5.3.2Town/ cityNîmes
    B.5.3.3Post code30029
    B.5.3.4CountryFrance
    B.5.4Telephone number+33466686715
    B.5.5Fax number+33466684262
    B.5.6E-mailbrigitte.lafont@chu-nimes.fr
    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 UVEDOSE 2.5mg (100 000 UI)
    D.2.1.1.2Name of the Marketing Authorisation holderCRINEX
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.1Product nameUVEDOSE
    D.3.4Pharmaceutical form Oral solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 solution in single-dose container
    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
    The study population consisted of healthy subjects (women and men) recruited at the University Hospital of Nîmes in order to be comparable in age (± 5 years) and sex (frequency matching) to patients included in a study carried out at the University Hospital of Nîmes with a similar design but involving patients with multiple sclerosis (VITADIMS cohort included in the original D-Lay MS study)
    La population de l’étude est constituée de sujets sains (femmes et hommes) recrutés au CHU de Nîmes de sorte à être comparables en âge (± 5ans) et en sexe (appariement de fréquence) aux patients inclus dans une étude réalisée au CHU de Nîmes avec un design proche mais portant sur des patients atteint de sclérose en plaque (cohorte VITADIMS incluse dans l’étude princeps D-Lay MS).
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers between the ages of 18 and 65
    Volontaires sains âgés de 18 à 65 ans
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028247
    E.1.2Term Multiple sclerosis like syndrome
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe and compare the evolution of circulating lymphocyte populations (Treg, Teff, Th1, Th17, Tr1, LB) in healthy subjects before and after 3 months of high dose vitamin D treatment or before and after 3 months of placebo
    Décrire et comparer l’évolution des populations lymphocytaires circulantes (Treg, Teff, Th1, Th17, Tr1, LB) chez des sujets sains avant et après 3 mois de traitement par vitamine D à forte dose ou avant et après 3 mois de placébo
    E.2.2Secondary objectives of the trial
    A- Compare the evolution of the activation state and the expression of adhesion molecules of different circulating lymphocyte populations (Treg, Teff, Th1, Th17, Tr1, LB) before and after 3 months of high dose vitamin D treatment versus before and after 3 months of placebo in healthy subjects.
    B- Compare the evolution of plasma Vitamin D levels before and after 3 months of high dose Vitamin D treatment versus before and after 3 months of placebo in healthy subjects
    C- Describe and compare the taxonomic characteristics and the metabolism of the intestinal microbiota after 3 months of high dose vitamin D treatment or after 3 months of placebo in healthy subjects
    D- To build a biobank (plasma, serum, PBMC, stool) from the samples collected.
    A- Comparer l’évolution de l’état d’activation et de l’expression de molécules d’adhésion de différentes populations lymphocytaires circulantes (Treg, Teff, Th1, Th17, Tr1, LB) avant et après 3 mois de traitement par vitamine D à forte dose ou avant et après 3 mois de placébo chez des sujets sains.
    B- Comparer l’évolution des taux plasmatiques de Vitamine D avant et après 3 mois de traitement par vitamine D à forte dose versus avant et après 3 mois de placébo chez les sujets sains
    C- Décrire et comparer les caractéristiques taxonomiques et le métabolisme du microbiote intestinal après 3 mois de traitement par vitamine D à forte dose ou après 3 mois de placébo chez des sujets sains.
    D- Constituer une biothèque (plasma, sérum, PBMC, selles) à partir des échantillons prélevés.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Healthy subject at least ≥ 18 years of age and less than ≤ 65 years of age.
    - Healthy subject must have given free and informed consent and signed the consent.
    - The healthy subject must be a member or beneficiary of a health insurance plan.
    - Women of childbearing potential must have effective contraception for the duration of the study. Effective contraception is defined as a low failure rate (less than 1% per year) when used correctly and consistently, such as implants, injectables, oral contraceptives, IUDs, abstinence or partner vasectomy. A urine pregnancy test will be performed at inclusion.
    • Sujet sain âgé d’au moins 18 ans (≥) et de moins de 65 ans (≤).
    • Le sujet sain doit avoir donné son consentement libre et éclairé et signé le consentement.
    • Le sujet sain doit être affilié ou bénéficiaire d’un régime d’assurance maladie.
    • Les femmes en âge de procréer doivent avoir un moyen de contraception efficace durant la durée de l’étude. Un moyen de contraception efficace est défini par un taux d’échec bas (moins de 1% par an) quand utilisé correctement et en permanence, comme par exemple les implants, les injectables, les contraceptions orales, les DIU, l’abstinence ou la vasectomie chez le partenaire. Un test de grossesse urinaire sera réalisé à l’inclusion.
    E.4Principal exclusion criteria
    - minor subject
    - Infectious disease or vaccination less than 3 months old.
    - Chronic psychiatric disease, or disease that in the opinion of the investigator may put the patient at risk or affect compliance.
    - Chronic inflammatory or dysimmune disease or subject on immunomodulatory or immunosuppressive therapy (including corticosteroids) within the last 3 months.
    - Uncontrolled epilepsy.
    - Known vitamin D deficiency secondary to active or other digestive disease (celiac disease, IBD, gastrectomy or bypass, cirrhosis, short bowel syndrome, nephrotic syndrome, hyperthyroidism, hypoparathyroidism, cancer, granulomatous pathology, lymphoma, rickettsiosis).
    - History of hypercalcemia, osteopenia or osteoporosis, urinary lithiasis, heart rhythm disorders.
    - Pathology requiring a daily intake of more than 1 gram of Calcium.
    - Contraindication to vitamin D3 treatment as mentioned on the VIDAL documentation of UVEDOSE.
    - Treatment affecting vitamin D metabolism other than corticosteroids: anti-epileptic drugs [phenobarbital, primidone, phenytoin], rifampicin, isoniazid, ketoconazole, 5-FU and leucovorin, thiazide diuretic
    - Present or past neurological symptoms that may suggest an undiagnosed inflammatory neurological pathology.
    - Active vitamin supplementation or intake of vitamin D-rich food supplements.
    - Subject is participating in another therapeutic study.
    - subject unable to express his consent
    - The subject is in an exclusion period determined by a previous study.
    - Subject is under court protection, guardianship, or conservatorship.
    - Subject refuses to sign consent.
    - Subject cannot be given informed information (unable to understand the study, language problem).
    • Sujet mineur
    • Pathologie infectieuse ou vaccination de moins de 3 mois.
    • Pathologie chronique psychiatrique, ou qui d’après l’investigateur, pourrait entrainer un risque pour le patient ou pourrait affecter la compliance.
    • Pathologie chronique inflammatoire ou dysimmunitaire ou sujet sous traitement immunomodulateur ou immunosuppresseur (y compris corticothérapie) dans les 3 derniers mois.
    • Epilepsie non contrôlée.
    • Carence en vitamine D connue secondaire à une pathologie digestive active ou autre (maladie cœliaque, MICI, gastrectomie ou bypass, cirrhose, syndrome de l’intestin court, syndrome néphrotique, hyperthyroïdie, hypoparathyroïdie, cancer, pathologie granulomateuse, lymphome, rickettsiose).
    • Antécédents d’hypercalcémie, d’ostéopénie ou d’ostéoporose, de lithiases urinaires, de troubles du rythme cardiaque.
    • Pathologie nécessitant un apport journalier de Calcium supérieur à 1 gramme.
    • Contre-indication à un traitement par vitamine D3 comme mentionné sur la documentation VIDAL de l’UVEDOSE.
    • Traitement affectant le métabolisme de la vitamine D autre que les corticoïdes : anti-épileptique [phénobarbital, primidone, phénytoïne], rifampicine, isoniazide, kétoconazole, 5-FU et leucovorin, diurétique thiazidique.
    • Symptomatologie neurologique présente ou passée pouvant faire évoquer une pathologie neurologique inflammatoire non diagnostiquée.
    • Supplémentation vitaminique active ou prise de compléments alimentaires riches en vitamine D.
    • Sujet participant à une autre étude thérapeutique.
    • Le sujet est en période d’exclusion déterminée par une étude précédente.
    • sujet hors d'état d'exprimer son consentement
    • Le sujet est sous sauvegarde de justice, sous tutelle ou sous curatelle.
    • Le sujet refuse de signer le consentement.
    • Il s’avère impossible de donner au sujet des informations éclairées (incapacité à comprendre l’étude, problème de langue).
    E.5 End points
    E.5.1Primary end point(s)
    Change in the level (%) of each circulating lymphocyte population (Treg, Teff, Th1, Th17, Tr1, LB) before and after 3 months of treatment with high-dose Vitamin D or placebo.
    Variation du taux (%) de chaque population lymphocytaire circulante (Treg, Teff, Th1, Th17, Tr1, LB) avant et après 3 mois de traitement par forte dose de Vitamine D ou placébo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 and 3 months
    T0 et 3 mois
    E.5.2Secondary end point(s)
    A- For each population (Treg, Teff, Th1, Th17, Tr1, LB) analyzed by FACS, quantification of the expression of activation and adhesion molecules and of pro- and anti-inflammatory cytokines (IL-10, IFNg and IL-17)
    B- Plasma level of Vitamin D.
    C- Nature and relative quantification of bacterial proteins and OTUs (bacterial taxonomic units) present in stool samples, identified by metagenomics and metabolomics.
    A- Pour chaque population (Treg, Teff, Th1, Th17, Tr1, LB) analysée par FACS, quantification de l’expression de molécules d’activation et d’adhésion et de cytokines pro et anti-inflammatoires (IL-10, IFNg et IL-17).
    B- Taux plasmatique de Vitamine D.
    C- Nature et quantification relative des protéines bactériennes et des OTU (unités taxonomiques bactériennes) présentes dans les échantillons de selles, identifiées en métagénomique et métabolomique.
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0 et 3 months
    3 months only for faeces
    T0 et 3 mois
    3 mois uniquement pour les selles
    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 No
    E.6.5Efficacy No
    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
    Description of activation markers and measurement of the intensity of changes induced in healthy subjects after 3 months of high-dose cholecalciferol treatment versus placebo
    Description des marqueurs d’activation et mesure de l’intensité des modifications induites chez des sujets sains après 3 mois de traitement par cholécalciférol à forte dose versus placébo
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 end of the study is defined as the date the database is frozen.
    La fin de l'étude est définie comme la date de gel de la base données.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    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 Decision2022-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-10-21
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