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    Summary
    EudraCT Number:2012-005332-29
    Sponsor's Protocol Code Number:D-Vitaal1.0
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-09
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-005332-29
    A.3Full title of the trial
    Prevention of depression and poor physical function in older persons with vitamin D supplementation
    Preventie van depressie en matig lichamelijk functioneren bij ouderen met vitamine D-suppletie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin D supplements to prevent depression and poor physical function in persons over 60 years
    Extra vitamine D ter preventie van depressie en verminderd lichamelijk functioneren bij 60-plussers
    A.3.2Name or abbreviated title of the trial where available
    D-Vitaal
    D-Vitaal
    A.4.1Sponsor's protocol code numberD-Vitaal1.0
    A.5.4Other Identifiers
    Name:D-VitaalNumber:12/354
    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 SponsorVU University Medical Centre
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Centre
    B.5.2Functional name of contact pointTrial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressVan der Boechorststraat 7
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 BT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031(0)204448439
    B.5.5Fax number0031(0)204446775
    B.5.6E-mailnm.vanschoor@vumc.nl
    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 Devaron
    D.2.1.1.2Name of the Marketing Authorisation holderVemedia Manufacturing BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDevaron
    D.3.2Product code Vitamin D
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codeVitamin D
    D.3.9.3Other descriptive nameCOLECALCIFEROL
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 typevitamin
    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 placeboTablet
    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
    depressive symptoms, poor physical functioning.
    depressieve symptomen, verminderd fysiek functioneren
    E.1.1.1Medical condition in easily understood language
    depressive symptoms, poor physical functioning
    depressieve symptomen, verminderd lichamelijk functioneren
    E.1.1.2Therapeutic area Not possible to specify
    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 primary objective of the D-Vitaal trial is to answer the following two questions:
    1. Does vitamin D supplementation decrease depressive symptoms in older persons?
    2. Does vitamin D supplementation improve physical performance and decrease functional limitations in older persons?
    Het primaire doel van de D-Vitaal studie is het beantwoorden van de volgende twee vragen:
    1. Kan vitamine D suppletie depressieve symptomen verminderen bij 60-plussers?
    2. Kan vitamine D suppletie het fysiek functioneren verbeteren en lichamelijke beperkingen verminderen bij 60-plussers?
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    investigate whether:
    - vitamin D supplementation decreases anxiety and improves cognition and quality of life in older persons
    - vitamin D supplementation prevents the development of full-blown major depression in older persons
    - vitamin D supplementation is a cost-effective strategy in the prevention of increasing depressive symptoms and functional limitations and declining physical performance.
    Secundaire studiedoelen:
    Er zal worden bekeken of:
    - vitamine D suppletie angst vermindert en cognitie en kwaliteit van leven verbetert bij 60-plussers
    - vitamine D suppletie full-blown depressie kan voorkomen bij 60-plussers
    - vitamine D suppletie een kosteneffectieve strategie is voor de preventie van de verergering van depressieve symptomen en lichamelijke beperkingen en de achteruitgang van het fysiek functioneren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age 60-80 years
    - mild depressive symptoms
    - at least one functional limitation
    - serum 25(OH)D levels between 15 and 50 nmol/l (winter) or 15 and 70 nmol/l (summer)
    - ability to comply with the study
    - leeftijd 60-80 jaar
    - milde depressieve symptomen
    - ten minste één lichamelijke beperking
    - serum 25(OH)D levels tussen de 15 en 50 nmol/l (winter) of 15 en 70 nmol/l (zomer)
    - in staat om aan het studieprotocol te houden
    E.4Principal exclusion criteria
    - full-blown depressive disorder
    - use of antidepressants
    - vitamin D (more than 400 IU/day) or calcium (more than 1000 mg/day) supplementation
    - major life-threatening illness
    - living in an aged-people's home or nursing home
    - diagnose depressie
    - gebruik van antidepressiva
    - vitamine D meer dan 400 IE/dag) of calcium (meer dan 1000 mg/dag) suppletie
    - ernstige, terminale ziekte
    - woonachtig in een verzorgingshuis of verpleeghuis
    E.5 End points
    E.5.1Primary end point(s)
    - change in CES-D score (depression questionnaire)
    - change in physical performance score
    - change in the number as well as the degree of functional limitations
    - verandering in CES-D score (depressievragenlijst)
    - verandering in score op fysiek functioneren
    - verandering in het aantal en de mate van lichamelijke beperkingen
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 maanden
    E.5.2Secondary end point(s)
    - change in anxiety, cogniton and quality of life scores
    - incidence of full-blown depression
    - change in timed-up-and-go test score
    - costs
    - verandering in scores op angst, cognitie, kwaliteit van leven
    - incidentie van depressiediagnose
    - verandering in score op de timed-up-and-go test
    - kosten
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months, 12 months
    6 maanden, 12 maanden
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) Yes
    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 Yes
    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
    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 months0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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 No
    F.3.3Specific vulnerable populations Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    older persons (60-80 years) with mild depressive symptoms and at least one functional limitation
    oudere mensen (60-80 jaar) met milde depressieve symptomen en ten minste één lichamelijke beperking
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    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 Decision2013-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
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