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    Summary
    EudraCT Number:2011-003010-17
    Sponsor's Protocol Code Number:-
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-003010-17
    A.3Full title of the trial
    Randomized double-blind intervention trial to assess the efficacy of vitamin D3 supplementation vs placebo in reducing hepatic steato-inflammation and cardio-metabolic risk profile in patients affected by type 2 diabetes and non-alcoholic fatty liver disease (NAFLD/NASH)
    STUDIO DI INTERVENTO RANDOMIZZATO CONTRO PLACEBO PER VALUTARE LA EFFICACIA DELLA SUPPLEMENTAZIONE ORALE CON VITAMINA D3 NEL RIDURRE LA STEATO-INFIAMMAZIONE EPATICA E NEL MODIFICARE IL PROFILO DI RISCHIO CARDIO-METABOLICO IN ADULTI DIABETICI AFFETTI DA STEATOSI/STEATOEPATITE NON ALCOOL-CORRELATA (NAFLD/NASH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized double-blind intervention trial to assess the efficacy of vitamin D3 supplementation vs placebo in reducing hepatic steato-inflammation and cardio-metabolic risk profile in patients affected by type 2 diabetes and non-alcoholic fatty liver disease (NAFLD/NASH)
    STUDIO D’INTERVENTO RANDOMIZZATO CONTRO PLACEBO PER VALUTARE L’EFFICACIA DELLA SUPPLEMENTAZIONE ORALE CON VITAMINA D3 NEL RIDURRE LA STEATOSI E L'INFIAMMAZIONE NEL FEGATO E I FATTORI DI RISCHIO CARDIOVASCOLARI IN ADULTI DIABETICI AFFETTI DA STEATOSI/STEATOEPATITE NON ALCOLICA (NAFLD/NASH)
    A.4.1Sponsor's protocol code number-
    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 SponsorAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    B.1.3.4CountryItaly
    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 supportFondi PRIN 2008
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSapienza Universita' di Roma
    B.5.2Functional name of contact pointDott.ssa Maria Gisella Cavallo
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico 155
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number3207172510
    B.5.5Fax number0649974698
    B.5.6E-mailgisella.cavallo@uniroma1.it
    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 DIBASE*OS GTT 10ML 10000UI/ML
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2000
    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 Yes
    D.3.11.13.1Other medicinal product typeSUPPLEMENTAZIONE VITAMINICA
    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
    Patients affected by type 2 diabetes and non alcoholic fatty liver disease- non alcoholic steato-hepatitis (NAFLD/NASH)
    Pazienti affetti da diabete di tipo 2 e steatosi-steatoepatite non alcool-correlata (NAFLD/NASH)
    E.1.1.1Medical condition in easily understood language
    Patients affected by type 2 diabetes and non alcoholic fatty liver disease- non alcoholic steato-hepatitis (NAFLD/NASH)
    Pazienti affetti da diabete di tipo 2 e steatosi-steatoepatite non alcool-correlata (NAFLD/NASH)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 evaluate the efficacy of oral supplementation with cholecalciferol in improving liver steato-inflammation in patients with type 2 diabetes mellitus and diagnosis of NAFLD or NASH.
    Valutare l’efficacia della supplementazione orale con colecalciferolo nel migliorare la steato-infiammazione epatica in pazienti con diabete mellito di tipo 2 e diagnosi di NAFLD o NASH.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of oral supplementation with cholecalciferol in improving cardio-metabolic risk profile (insulin-sensitivity, lipids, sistemic inflammation, glucose tolerance, body fat distribution) in patients with type 2 diabetes mellitus and diagnosis of NAFLD or NASH.
    Valutare l’efficacia della supplementazione orale con colecalciferolo nel migliorare il profilo di rischio cardio-metabolico (sensibilità insulinica, assetto lipidico, markers di infiammazione sistemica, tolleranza glucidica, distribuzione del grasso corporeo)in pazienti con diabete mellito di tipo 2 e diagnosi di NAFLD o NASH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged between 25 and 65 years
    Diagnosis of Type 2 Diabetes Mellitus
    Presence of ultrasound detected fatty liver confirmed by MRI
    acceptance of informed consent
    Età compresa tra 25 e 65 anni
    Diagnosi di Diabete Mellito di tipo 2
    Presenza di steatosi epatica rilevata alla ecografia epatica e confermata dall’esecuzione di RMN
    Accettazione consapevole del consenso informato
    E.4Principal exclusion criteria
    e <25 or> 65 years
    History of alcohol abuse (> 40 mg / day for men,> 20 mg / day for women)
    Acute or chronic liver infections autoimmune hepatitis
    History of cancer
    Other causes of liver disease (hemochromatosis, Wilson's disease)
    renal failure
    Hyper / hypoparathyroidism
    chronic enteropathies
    Hypersensitivity to any of the excipients or cholecalciferol hypercalcemia, hypercalciuria (nephrolithiasis, nephrocalcinosis) Therapy with vitamin D, calcium or other drugs affecting bone metabolism, calcium and vitamin D metabolism (anticonvulsants, glucocorticoids, antacids containing aluminum, cholestyramine ) Pregnancy and lactation
    Età &lt; 25 anni o &gt; 65 anni
    Storia di abuso alcolico (&gt;40 mg/die per l’uomo, &gt;20 mg/die per la donna)
    Infezioni epatiche croniche o acute in atto
    Epatite autoimmune
    Storia di neoplasie
    Altre cause di epatopatie (Emocromatosi, Morbo di Wilson)
    Insufficienza renale
    Iper/ipoparatiroidismo
    Enteropatie croniche
    Ipersensibilità al colecalciferolo o a uno qualsiasi degli eccipienti Ipercalcemia, ipercalciuria Calcolosi renale (nefrolitiasi, nefrocalcinosi) Terapia con vitamina D, calcio o altri farmaci che influenzino il metabolismo osteo-calcico e il metabolismo della vitamina D (anticonvulsivanti, glucocorticoidi, antiacidi contenenti alluminio, colestiramina) Gravidanza e allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of hepatic steatosis in patients with NAFLD and reduction in steatosis, inflammation and liver fibrosis in patients with NASH treated with Vitamin D oral supplementation
    Riduzione della steatosi epatica nei soggetti affetti da NAFLD e riduzione della steatosi, dell’infiammazione e della fibrosi epatica nei soggetti affetti da NASH dopo trattamento con supplementazione orale di vitamina D
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    The secondary objective of this study is to assess changes in the cardio-metabolic risk profile in diabetic patients treated with Vitamin D oral supplementation
    L’obiettivo secondario dello studio è valutare le modificazioni del profilo di rischio cardio-metabolico
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 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 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    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.1.1Number of subjects for this age range: 0
    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 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 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)
    ORAL VITAMIN D SUPPLEMENTATION WILL BE PERFORMED FOR 6 MONTHS, FOLLOWED BY A 6 MONTHS LASTING FOLLOW UP (MRI EVALUATION OF LIVER STEATOSIS, BIOCHEMICAL MEASUREMENTS OF CARDIO-METABOLIC RISK MARKERS)
    IL TRATTAMENTO CON VITAMINA D AVRA' UNA DURATA DI 6 MESI, SEGUITI DA 6 MESI DI FOLLOW- UP CON VISITE TRIMESTRALI CON VALUTAZIONE DELLE MODIFICAZIONI A CARICO DEL PARENCHIMA EPATICO E DEL PROGFILO DI RISCHIO CARDIO-METABOLICO, COME DESCRITTO NEL PROTOCOLLO
    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 Decision2011-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
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