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    Summary
    EudraCT Number:2016-003673-18
    Sponsor's Protocol Code Number:1062016
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2016-09-19
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-003673-18
    A.3Full title of the trial
    Can we with vitamin D3, improve the innate immune system?
    Kunnen we door middel van een behandeling met vitamine D3, het aangeboren
    immuunsysteem verbeteren?
    Peut-on au moyen d'un traitement avec de la vitamine D3, améliorer le système immunitaire inné?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can we with vitamin D, improve the immune system?
    Kunnen we met vitamine D het immuunsysteem verbeteren
    Pouvons-nous améliorer le système d’immunité avec de la vitamine D?
    A.4.1Sponsor's protocol code number1062016
    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 SponsorUZ Brussel
    B.1.3.4CountryBelgium
    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 supportUZ Brussel
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Brussel
    B.5.2Functional name of contact pointPediatrie Hematologie/oncologie
    B.5.3 Address:
    B.5.3.1Street Addresslaarbeeklaan 101
    B.5.3.2Town/ cityJette
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.6E-mailjvdwerff@uzbrussel.be
    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 D-cure
    D.2.1.1.2Name of the Marketing Authorisation holderSMB
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameD-cure
    D.3.2Product code BE461173
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INND-cure
    D.3.9.3Other descriptive nameCHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
    D.3.9.4EV Substance CodeSUB11818MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immunological problems such as hypogammaglobulinemia with clinical recurrent infections such as sinusitis , pneumonia , otitis , skin infections and gastrointestinal infections.
    Immunologische problematiek zoals hypogammaglobulinemie met klinisch recidiverende infecties zoals sinusitis, pneumonie, otitis, huidinfecties en gastro-intestinale infecties.
    Des problèmes immunologiques comme hypogammaglobulinemia avec des infections récurrentes: sinusite, la pneumonie, l'otite, les infections des peau et des infections gastro-intestinales.
    E.1.1.1Medical condition in easily understood language
    Children with immunological problems .
    Kinderen met immunologische problemen.
    Les enfants avec des problèmes immunologiques.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aims of this study is to find answers to some questions: 1. Can we through changes in the vitamin D state in PID (primary immune deficiency patients) with impaired Toll-Like Receptor Response trigger an immunological effect? These modifications take place by administration of vitamin D3 supplements. 2. Is there a pre-interventional connection between cholesterol or / and vitamin D level and the current Toll-like receptor activity? 3. If the patients had previously received a vitamin D treatment during their first year of life, then has this an influence on the current status of vitamin D? 4. Is there post-interventional a noticeable difference compared to pre-interventional in total cholesterol or / and vitamin D levels?
    De doelstellingen van deze studie is antwoorden te vinden op een aantal vragen: 1. Kunnen we door wijzigingen in het vitamine D metabolisme bij PID’s (primaire immuundeficiëntie patiënten) met een verminderde Toll-Like Receptorrespons een immunologisch effect teweegbrengen? Deze wijzigingen vinden plaats door het toedienen van vitamine D3 supplementen. 2. Is er pre-interventioneel een verband te vinden tussen het cholesterol of/en vitamine D level en de huidige Toll-like receptor activiteit? 3. Indien de patiënten voordien een vitamine D kuur gekregen hebben tijdens hun eerste levensjaar, heeft dit dan een invloed op de huidige vitamine D status? 4. Is er post-interventioneel een verschil merkbaar ten opzichte van pre-interventioneel in het totaal cholesterol of/en vitamine D niveau?
    Cette étude a comme objectif de trouver des réponses aux prochaines questions: 1. Pouvons-nous déclencher un effet immunologique chez les PID (patients avec un déficit immunitaire primaire) avec une réponse affaiblie des recepteurs Toll-like en modifiant le metabolisme de la vitamine D. Ces modifications ont lieu par l'administration de suppléments de vitamine D3. 2. Y at-il un lien entre le cholestérol et / ou le niveau de vitamine D et l'activité actuelle du récepteur Toll-like avant l'intervention? 3. Peut-on trouver une différence du taux de vitamine D actuelle entre Les patients ayant bénéficié d'un traitement de vitamine D lors de leur première année de vie et les patients n’ayant reçu aucun traitement équivalent ? 4. y a-t-il une différence significative pour le niveau de vitamine D ou / et le cholesterol total avant et après l'intervention.
    E.2.2Secondary objectives of the trial
    The aims of this study is to find answers to some questions: 1. Can we through changes in the vitamin D state in PID (primary immune deficiency patients) with impaired Toll-Like Receptor Response trigger an immunological effect? These modifications take place by administration of vitamin D3 supplements. 2. Is there a pre-interventional connection between cholesterol or / and vitamin D level and the current Toll-like receptor activity? 3. If the patients had previously received a vitamin D treatment during their first year of life, then has this an influence on the current status of vitamin D? 4. Is there post-interventional a noticeable difference compared to pre-interventional in total cholesterol or / and vitamin D levels?
    De doelstellingen van deze studie is antwoorden te vinden op een aantal vragen: 1. Kunnen we door wijzigingen in het vitamine D metabolisme bij PID’s (primaire immuundeficiëntie patiënten) met een verminderde Toll-Like Receptorrespons een immunologisch effect teweegbrengen? Deze wijzigingen vinden plaats door het toedienen van vitamine D3 supplementen. 2. Is er pre-interventioneel een verband te vinden tussen het cholesterol of/en vitamine D level en de huidige Toll-like receptor activiteit? 3. Indien de patiënten voordien een vitamine D kuur gekregen hebben tijdens hun eerste levensjaar, heeft dit dan een invloed op de huidige vitamine D status? 4. Is er post-interventioneel een verschil merkbaar ten opzichte van pre-interventioneel in het totaal cholesterol of/en vitamine D niveau?
    Cette étude a comme objectif de trouver des réponses aux prochaines questions: 1. Pouvons-nous déclencher un effet immunologique chez les PID (patients avec un déficit immunitaire primaire) avec une réponse affaiblie des recepteurs Toll-like en modifiant le metabolisme de la vitamine D. Ces modifications ont lieu par l'administration de suppléments de vitamine D3. 2. Y at-il un lien entre le cholestérol et / ou le niveau de vitamine D et l'activité actuelle du récepteur Toll-like avant l'intervention? 3. Peut-on trouver une différence du taux de vitamine D actuelle entre Les patients ayant bénéficié d'un traitement de vitamine D lors de leur première année de vie et les patients n’ayant reçu aucun traitement équivalent ? 4. y a-t-il une différence significative pour le niveau de vitamine D ou / et le cholesterol total avant et après l'intervention.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Application for a Toll-like receptor research because of immunological problems such as hypogammaglobulinemia with clinical recurrent infections such as sinusitis, pneumonia, otitis, skin infections and gastrointestinal infections. No distinction is made in this study on the gender or age.
    Aanvraag voor een Toll Like Receptor onderzoek vanwege immunologische problematiek zoals hypogammaglobulinemie met klinisch recidiverende infecties zoals sinusitis, pneumonie, otitis, huidinfecties en gastro-intestinale infecties. Er wordt geen onderscheid gemaakt in deze studie omtrent het geslacht of de leeftijd.
    Une demande pour la recherche des recepteurs toll-like en raison de problèmes immunologiques comme hypogammaglobulinémie avec des infections récurrentes telles que la sinusite, la pneumonie, l’otite, les infections cutanées et les infections gastro-intestinales. Cette étude ne tient pas compte ni de l’âge ni du sexe des patients.
    E.4Principal exclusion criteria
    In case of refusal of the patient or parents.
    Patient with sarcoidosis or disease Besnier-Book Schaumann.
    Known hypersensitivity to any of the ingredients in the drug.
    Hypercalcemia and in particular idiopathic hypercalcemia in infants.
    Hypercalciuria and, in particular, when it is accompanied with renal lithiasis.
    Patients with renal insufficiency, lithiasis or heart disease because these patients have a higher risk of hypercalcaemia.
    Patients taking drugs such as digitalis preparations, thiazide diuretics, phenytoin, carbamazepine and prymidone.
    Bij weigering van patiënt of ouders.
    Patiënt met sarcoïdose of ziekte van Besnier-Boek-Schaumann.
    Gekende overgevoeligheid voor één van de bestanddelen in het geneesmiddel.
    Hypercalciëmie en in het bijzonder idiopathische hypercalciëmie bij zuigelingen.
    Hypercalciurie en in het bijzonder wanneer zij gepaard gaat met renale lithiasis.
    Patiënten met een nierinsufficiëntie, lithiase of een hartziekte, omdat deze patiënten een hoger risico op hypercalciëmie hebben.
    Patiënten die geneesmiddelen als digitalispreparaten, thiazide diuretica, fenytoïne, carbamazepine en prymidone gebruiken.
    En cas de refus du patient ou de ses parents.
    Patient avec la sarcoïdose ou la maladie de Besnier-Book Schaumann.
    Une hypersensibilité connue à l'un des composants du médicament.
    Hypercalcémie et en particulier l'hypercalcémie idiopathique chez les nourrissons.
    Hypercalciurie et, en particulier, quand il est accompagné d'une lithiase rénale.
    Les patients présentant une insuffisance rénale, lithiase ou d'une maladie cardiaque parce que ces patients ont un risque plus élevé d'hypercalcémie.
    Les patients qui prennent des médicaments tels que des préparations digitaliques, diurétiques, thiazidiques, phénytoïne, carbamazépine et primidone.
    E.5 End points
    E.5.1Primary end point(s)
    An improvement of the immune system in the clinical field and in blood levels.
    Een verbetering van het immuunsysteem zowel op klinisch vlak als op bloedwaarden.
    Une amélioration du système immunitaire tant sur le plan clinique que les valeurs sanguines.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1/6/2018
    1/6/2018
    E.5.2Secondary end point(s)
    Vitamine D given in beginning of life has an advantage on the current immune system.
    Vitamine D gegeven in het begin van het leven heeft nu een immunologische voordeel op de huidige resultaten.
    La vitamine D donné le debut de la vie et une advantage immunologique sur les résultats actuelles.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/6/2018
    1/6/2018
    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 Yes
    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 No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    De immunologische resultaten pre-interventioneel met post-interventioneel
    Immunological results pre-interventional with post-interventional
    E.8.2.4Number of treatment arms in the trial1
    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
    after 3 months the study is finished for the individual patients.
    na 3 maanden is de studie afgelopen voor de patient.
    Après 3 mois l’étude est terminée pour le patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    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 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 Information not present in EudraCT
    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)
    none
    geen
    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 Decision2016-11-07
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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