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    Summary
    EudraCT Number:2012-002217-19
    Sponsor's Protocol Code Number:232100-0024
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-27
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-002217-19
    A.3Full title of the trial
    Postoperative treatment with Vitamin D for patients with a history of Bariatric Surgery in C and U County.
    Postoperativ Substitutionsbehandling med D-vitamin efter Obesitaskirurgi i CoU-län
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Postoperative treatment with Vitamin D for patients with a history of Bariatric Surgery in C and U County.
    Postoperativ Substitutionsbehandling med D-vitamin efter Obesitaskirurgi i CoU-län
    A.3.2Name or abbreviated title of the trial where available
    SOL
    A.4.1Sponsor's protocol code number232100-0024
    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 SponsorDept of Surgery
    B.1.3.4CountrySweden
    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 supportCounty of Uppsala
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportEdvin Erikssons fond, Uppsala
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Surgery
    B.5.2Functional name of contact pointKirurgmottagningen
    B.5.3 Address:
    B.5.3.1Street AddressSjukhusvägen
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46186110000
    B.5.6E-mailhella.hultin@surgsci.uu.se
    B.Sponsor: 2
    B.1.1Name of SponsorLandstinget i Uppsala
    B.1.3.4CountrySweden
    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 supportLandstinget i Uppsala län
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportEdvin Erikssons fond, Uppsala Universitet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLandstinget i Uppsala
    B.5.2Functional name of contact pointAkademiska sjukhuset, kirurgmottagn
    B.5.3 Address:
    B.5.3.1Street AddressSjukhusvägen
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75185
    B.5.3.4CountrySweden
    B.5.4Telephone number+460186110000
    B.5.6E-mailhella.hultin@surgsci.uu.se
    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 Vitamin D3 Streuli
    D.2.1.1.2Name of the Marketing Authorisation holderStreuli Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameVitamin D3 Streuli
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypovitaminosis D after bariatric surgery
    D-vitaminbrist efter bariatrisk kirurgi
    E.1.1.1Medical condition in easily understood language
    Hypovitaminosis D after surgery for obesity
    D-vitaminbrist efter överviktskirurgi
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    To study the effect on vitamin D levels after bariatric surgery by administrating an injection of cholecalciferol at one occasion, compared to no treatment at all.
    Studera effekten av en injektion cholecalciferol på D-vitaminnivån hos överviktsopererade, jämfört med ingen behandling alls.
    E.2.2Secondary objectives of the trial
    not applicable
    ej relevant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Gastric bypass or duodenal switch performed in 2008-2011 at Akademiska hospital in Uppsala.
    Geomgått gastric bypass eller duodenal switch vid Akademiska sjukhuset i Uppsala 2008-2011, kvinnor och män.
    E.4Principal exclusion criteria
    Medication that influences calciumhomeostasis. Planned vacation in a sunny country during the study period or use of cosmetic solarium.
    Pågående medicinering som påverkar kalciumhomeostas, planerad "solresa" under studieperioden eller bruk av kosmetiskt solarium.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in vitamin D level before and three and six months after administration of cholecalciferol.
    Skillnad i vitamin D nivå före och efter tre och sex månader efter injektion av kolecalciferol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three and six months post injection.
    Tre och sex månader efter injektionen.
    E.5.2Secondary end point(s)
    Not applicable
    ej relevant
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    ej relevant
    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 Yes
    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 No
    E.8.1.1Randomised Yes
    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 No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 years1
    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 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: 220
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state220
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 220
    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
    Ingen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-10
    P. End of Trial
    P.End of Trial StatusOngoing
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