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    Summary
    EudraCT Number:2014-002639-32
    Sponsor's Protocol Code Number:3310
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-002639-32
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, parallel-group trial of Vitamin D supplementation compared to placebo in people presenting with their First Episode of psychosis (DFEND) Neuroprotection Design
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial of Vitamin D supplementation compared to placebo in people presenting with their First Episode of psychosis.
    A.3.2Name or abbreviated title of the trial where available
    DFEND
    A.4.1Sponsor's protocol code number3310
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12424842
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportStanley Medical Institute
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Psychiatry
    B.5.2Functional name of contact pointDr Fiona Gaughran
    B.5.3 Address:
    B.5.3.1Street AddressDept of Psychosis Studies, De Crespigny Park
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442032286000
    B.5.5Fax number+442032284312
    B.5.6E-mailfiona.1.gaughran@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportStanley Medical Institute
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Psychiatry
    B.5.2Functional name of contact pointDr Fiona Gaughran
    B.5.3 Address:
    B.5.3.1Street AddressDept of Psychosis Studies, De Crespigny Park
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442032286000
    B.5.5Fax number+442032284312
    B.5.6E-mailfiona.1.gaughran@kcl.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 Vigantol Oil
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Selbstmedikation GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 INNColecalciferol
    D.3.9.3Other descriptive nameColecalciferol
    D.3.9.4EV Substance CodeSUB11818MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000
    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 drops, 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
    First Episode Psychosis
    E.1.1.1Medical condition in easily understood language
    First Episode Psychosis
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037234
    E.1.2Term Psychosis
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the addition of 120,000 IU monthly of vitamin D (cholecalciferol) supplement to standard treatments is more effective than placebo in improving outcomes (Positive And Negative Syndrome Scale Total score – PANSS) at six month follow-up in those with First Episode Psychosis.
    E.2.2Secondary objectives of the trial
    To examine PANSS Total score and related subscores at 3 and 6 months, and a broader range of clinically-relevant outcomes based on Global Assessment of Function (GAF), the Calgary Depression Scale, cardiovascular risk markers and 25OHD vitamin D concentrations.
    We will examine primary and secondary outcomes in (a) all participants and (b) in a subgroup of patients with suboptimal vitamin D concentrations at baseline (except for the secondary outcome of 25 (OH) D concentrations which will examine in all participants.
    Tertiary Objective: To collect data on inflammatory/immune markers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients within EIS and FEP inpatient units who meet the following criteria will be invited to participate in the study:

    a. Aged between 18-65 years old including women of child-bearing age

    b. Having a diagnosis of functional psychosis FEP defined according to ICD-10 criteria for psychosis (codes F20-29 and F30-33)
    c. Willing to agree to refrain from taking multivitamin or non-study vitamin D supplements (including cod liver oil) that exceed 400IU/day throughout the study.

    d. Willing to give a blood vitamin D sample at baseline

    e. Patients who are able and have given written informed consent.
    E.4Principal exclusion criteria
    a) Known intolerance of Vitamin D2 or D3 or known allergy to any of the trial medications
    b) Those who are currently taking vitamin D supplements at a dose exceeding 400IU/day
    c) Those who have taken cardiac glycosides, calcium channel blockers or oral, intramuscular or intravenous corticosteroids , bendroflumethiazide, isoniazid or rifampicin in the past one month
    d) Known active tuberculosis, sarcoidosis, hypo or hyperparathyroidism, past or present nephrolithiasis(renal stones), suspected or diagnosed hepatic or renal dysfunction, any malignancy other than non-melanoma skin cancer not in remission for ≥ 3 years, calcium disorders
    e) Baseline corrected serum calcium > 2.6mmol/L
    f) Patients with known history of hypercalcaemia
    g) Pregnant or breast-feeding women and women planning a pregnancy
    h) Patients lacking the capacity to provide written informed consent
    i) Those who do not have sufficient English to complete the core assessments with the available assistance
    E.5 End points
    E.5.1Primary end point(s)
    Total PANSS score at 6 month follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after inclusion
    E.5.2Secondary end point(s)
    Total PANNS score at 3 months
    PANSS Positive Scale sub score at 3 and 6 months
    PANSS Negative Scale sub score at 3 and 6 months
    PANSS General Psychopathology Scale sub score at 3 and 6 months
    Global Assessment of Function (GAF) at 6 months
    Calgary Depression Scale (CDS) at 6 months.
    Waist Circumference (cm) at 6 months
    BMI (kg/m2) at 6 months
    HbA1c (mmol/mol) at 6 months
    Total Cholesterol (mmol/L) at 6 months
    CRP (mg/L) at 6 months
    250 (OH)D Concentrations at 6 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 and 6 months
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned5
    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
    Patient's final follow up telephone call
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-07-20. Yes
    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 state240
    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)
    No provision for supply of Trial IMP post trial. Standard Care will apply.
    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 Decision2015-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-20
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