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    Summary
    EudraCT Number:2016-002460-13
    Sponsor's Protocol Code Number:VITDALIZEUK
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-002460-13
    A.3Full title of the trial
    Effect of High-Dose Vitamin D3 on 28-Day Mortality in Adult Critically Ill Patients with Severe Vitamin D Deficiency
    The UK arm of an International Multi-Centre, Placebo-Controlled, Phase III Double-Blind trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    UK Arm of the Effect of High-Dose Vitamin D3 on 28-Day Mortality in Adult Critically Ill Patients with Severe Vitamin D Deficiency.
    A.3.2Name or abbreviated title of the trial where available
    VITDALIZE UK
    A.4.1Sponsor's protocol code numberVITDALIZEUK
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03188796
    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 SponsorMedical Unviersity of Graz
    B.1.3.4CountryAustria
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointBirgit Whitman
    B.5.3 Address:
    B.5.3.1Street AddressAston Webb Building,
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailresearchgovernance@contacts.bham.ac.uk
    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 Oleovit D3 Tropfen
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi GmbH, Graz
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameOleovit D3 Tropfen
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCholecalciferol
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4,000 to 540,000
    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
    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
    Critically ill patients who are in intensive care and are found to be severely vitamin D deficient (25(OH)D ≤12ng/ml (30nmol/L)).
    E.1.1.1Medical condition in easily understood language
    Critically ill patients who are in intensive care and are found to have severe vitamin D deficient (low vitamin D levels).
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10059936
    E.1.2Term Blood 25-hydroxycholecalciferol
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10053813
    E.1.2Term Blood 25-hydroxycholecalciferol decreased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080368
    E.1.2Term Vitamin D3 deficiency
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077264
    E.1.2Term Critical illness
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Research Question
    -----------
    In adult critically ill patients with severe vitamin D deficiency, does high dose oral vitamin D3 replacement therapy improve 28-day mortality?

    Objective
    ----------
    To compare if treating severe vitamin D deficiency with high dose oral vitamin D3 replacement compared to placebo in adult critically ill patient’s decreases 28-day mortality.
    E.2.2Secondary objectives of the trial
    Research Question
    ----------
    In adult critically ill patients with severe vitamin D deficiency, does high dose oral vitamin D3 replacement improve longer-term mortality, morbidity and patient specific outcomes?

    In addition, is it cost-effective to test for and treat severe vitamin D deficiency with high dose oral vitamin D3 (UK only)?

    Objectives
    Does testing for and treating severe vitamin D deficiency with high dose vitamin D3 replacement in adult critically ill patients:

    • Reduce organ dysfunction
    • Reduce hospital and ICU length of stay and mortality
    • Improve long-term survival
    • Reduce readmission to hospital
    • Improve activities of daily living
    In the UK arm additionally:
    • Improve health-related quality of life at 90 days and 1 year
    • Reduce disability at 90 days and 1 year
    • Reduce health care utilisation to 1 year
    • Is cost-effective in the NHS setting
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An optional sample will be taken as part of a future research project.
    E.3Principal inclusion criteria
    1. Patients ≥18 years
    2. Anticipated ICU stay ≥ 48 hours
    3. Admission to ICU ≤ 72 hours before screening for VDD
    4. Severe VDD (25(OH)D ≤12ng/ml (30nmol/L)) using either the hospital's clinical laboratory or rapid bedside testing after ICU admission
    E.4Principal exclusion criteria
    1. Severe gastrointestinal dysfunction (>400ml nasogastric tube residual volume) /unable to receive trial medication
    2. Not expected to survive initial 48 hours of admission or treatment withdrawal imminent within 24 hours.
    3. Patient with DNAR (Do Not Attempt Resuscitation) orders in place
    4. Hypercalcemia (>2.65mmol/l corrected calcium and/or >1.35mmol/l ionized calcium at screening)
    5. Known kidney stones within the last 12 months
    6. Known active tuberculosis within the last 12 months
    7. Known sarcoidosis within the last 12 months
    8. Women of child bearing age who have tested positive for pregnancy or who are lactating
    9. Known hypersensitivity to the trial drug or excipient
    10. Medical team deem it not suitable to include patient
    11. Known prisoners in the custody of HM Prison and Probation services
    E.5 End points
    E.5.1Primary end point(s)
    All-cause mortality at 28-days after randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    • 90 day and 1 year mortality
    • ICU and hospital mortality
    • Hospital and ICU length of stay (starting at day 0, ending at discharge from the trial site or day 90 or mortality, whatever occurs first)
    • Change in organ dysfunction on day five as measured by Sequential Organ Function Assessment score (SOFA), number of organ failures (0-6; defined as > 2 SOFA points in each of the 6 categories)
    • Hospital and ICU readmission until day 90
    • Discharge destination (home, rehabilitation, other hospital)
    • Katz Activities of Daily Life at day 90
    • Self-reported infections requiring antibiotics until day 90
    • Health-related quality of life (EQ-5D-5L) at 90 days and 1 year
    • Disability assessment (WHO-DAS 2.0) at 90 days and 1 year
    • Secondary health care utilisation in the first year (ICU and hospital length of stay, readmissions and utilisation of hospital and community care resources after hospital discharge one year after randomisation), from Hospital Episode Statistics, civil registry data held by NHS Digital and patient questionnaires

    Health economics analysis
    • Cost effectiveness of screening for and treating VDD in critical illness
    • Cost per quality-adjusted life year gained one year after randomisation and at end of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 days, 28 days, 90 days, 1 year
    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 Yes
    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 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.8.3 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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Germany
    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
    The end of trial will be 6 months after the last data capture.
    ‘Last data capture’ is defined as being the last data capture for the whole trial (all participating countries).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1.1Number 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) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1800
    F.4.2.2In the whole clinical trial 2400
    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)
    The patients will continue on their standard of care pathway once completion of trial follow-up.

    Vitamin D is readily available and the patients GP will be informed of their inclusion in the trial and their screening vitamin D result. It will be at the discretion of the GP if the wish to continue vitamin D treatment (please see attached GP letter).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation University of Birmingham
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-01
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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