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    The EU Clinical Trials Register currently displays   36093   clinical trials with a EudraCT protocol, of which   5934   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-011264-11
    Sponsor's Protocol Code Number:25021960
    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:2009-11-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-011264-11
    A.3Full title of the trial
    A randomized, double blind, placebo controlled, phase II, multi-centre pilot study to investigate the effects of vitamin D2 or D3 supplementation on metabolic parameters in people at risk of type 2 diabetes.
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D Supplementation in People at Risk of Type 2 Diabetes V1.3
    A.4.1Sponsor's protocol code number25021960
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberApplied for
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorQueen Mary University of 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorMedical Research Council
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 KGaA Damstadt
    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.3.1Product nameCholecalciferol (vitamin D3)
    D.3.4Pharmaceutical form Oral drops*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCholecalciferol
    D.3.9.1CAS number 67-97-0
    D.3.9.3Other descriptive nameVitamin D3
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20,000
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 Sterogyl
    D.2.1.1.2Name of the Marketing Authorisation holderDB Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameErgocalciferol (vitamin D2)
    D.3.4Pharmaceutical form Oral drops*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNErgocalciferol
    D.3.9.1CAS number 50-14-6
    D.3.9.3Other descriptive nameVitamin D2
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20,000
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 liquid
    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
    Preventing/ delaying the onset of type 2 diabetes mellitus and cardiovascular risk factors.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.0
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main aim of this study is to determine whether a monthly dose of 100,000 IU of vitamin D2 or D3 (the two forms of vitamin D currently available in the market) can lead to a reduction in sugar levels (glycaemia as measured by HbA1c) in people at high risk of developing diabetes.
    E.2.2Secondary objectives of the trial
    To determine whether
    • vitamin D at the proposed dose is safe and well-tolerated by trial participants.
    • vitamin D2 or vitamin D3 are equally potent or whether there is a biological advantage of one over the other.
    • vitamin D supplementation improves risk factors associated with cardiovascular disease and strokes.
    • the feasibility and acceptability of high dose vitamin D supplementation to inform a future trial with diabetes and/or cardiovascular endpoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    4.1 Inclusion Criteria
    a) Number of participants: 342 (divided between Cambridge and East London, see sample size calculations in appendix)
    b) Age 30-75yrs.
    c) All ethnic groups
    d) People at risk of developing T2D as defined by:
    The Cambridge Risk Score (CRS) [80-82]. The CRS cut-offs would be 0.236 for the Black/Caribbean population, 0.127 for South Asians and 0.199 for Caucasians [83]. For other groups the cut-off for Caucasians will be used
    Or
    Impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) defined by current WHO criteria, where this information is available in medical records, or in the records of studies in which participants have consented to being re-approached to consider taking part in future studies.

    Or
    Non-diabetic hyperglycaemia (defined as HbA1c from 5.5% to 6.49%), where this information is available in medical records, or in the records of studies in which participants have consented to being re-approached to consider taking part in future studies.
    e) Can provide informed consent for participation in the trial.
    E.4Principal exclusion criteria
    Exclusion Criteria

    • Known T2D or use of oral hypoglycaemic agents (GP records, participant history)
    • Random blood glucose during initial screening >11 mmol/l (Screening)
    • Known intolerance to vitamin D2 or D3 (GP records, participant history)
    • Currently taking vitamin D supplements (GP records, participant history)
    • Prior history of hypercalcaemia (serum calcium >2.65 mmol/l) (GP records, participant history)or point of care ionised calcium >1.3mmol/l. (Screening)
    • Stage 4 or worse chronic kidney disease (eGFR (estimated glomerular filtration rate) < 30 ml/min) (GP records, participant history)
    • History of significant liver disease (AST (aspartate aminotransferase) >3 x upper limit of normal (ULN) or serum bilirubin > 2.5 x ULN) (GP records, participant history)
    • Past or current history of renal stones (GP records, participant history)
    • Known hyperparathyroidism (GP records, participant history)
    • Known active sarcoidosis, tuberculosis or malignancy (GP records, participant history)
    • Taking cardiac glycosides, thiazide diuretics or corticosteroids in the past one month (GP records, participant history)
    • Documented anaemia of <11g% or known haemoglobinopathy such as sickle cell anaemia and beta or alpha thalassemia (GP records, participant history)
    • Planned travel out of the London area or Cambridge (depending of site of recruitment) within 8 weeks of enrolment such that it will disrupt monitoring of the participant (Participant history)
    • Breast feeding, pregnancy or planning a pregnancy (Participant history)

    NB – 1. Women of childbearing potential and men must be willing to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) from the time consent is signed until 6 weeks after the end of treatment.
    2. Women of childbearing potential must have a negative pregnancy test result within 7 days prior to being registered for the protocol therapy. (NOTE: Subjects are considered not of child bearing potential only if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or if they are postmenopausal).
    3. Women must not be breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Glycaemia as assessed by HbA1c at the final visit
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 Information not present in EudraCT
    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
    Trial will end when 342 participants have been recruited and completed the protocol.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state342
    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)
    Participants who are found to be vitamin D deficient will be referred back to their General Practitioner at the end of the trial via a letter who can then decided if they wish for their patient to be started / continued on vitamin D supplements.
    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 Decision2009-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-01
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