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    Summary
    EudraCT Number:2011-000868-95
    Sponsor's Protocol Code Number:DvitKOL01022011
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-05-03
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-000868-95
    A.3Full title of the trial
    Vitamin D and COPD
    A randomised, doubble-blind, placebo-controlled trial of the effect of vitamin D on withdrawal from pulmonary rehabilitation and exercise endurance
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin D and COPD
    A.3.2Name or abbreviated title of the trial where available
    DvitKOL
    A.4.1Sponsor's protocol code numberDvitKOL01022011
    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 SponsorHvidovre Hospital
    B.1.3.4CountryDenmark
    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 supportHvidovre Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportPharma Vinci A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHvidovre Hospital
    B.5.2Functional name of contact pointLungemedicinsk Sektion
    B.5.3 Address:
    B.5.3.1Street AddressKettegård Allé 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number4538623165
    B.5.5Fax number4538623615
    B.5.6E-mailmia.moberg@hvh.regionh.dk
    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 BioVinci Mega D-vitamin 38 mcg
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Vinci A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 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.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 typeCholecalciferol is extracted from the fat from sheep wool
    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
    Chronic obstructive pulmonary disease (COPD)
    E.1.1.1Medical condition in easily understood language
    Chronic bronchitis, emphysema or "smoker's lung"
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009032
    E.1.2Term Chronic obstructive lung disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation. The main objective being examination of the effect on withdrawal rates and walking distance
    E.2.2Secondary objectives of the trial
    To examine the effect of vitamin D in patients with COPD relating to bone health, inflammation, health related quality of life, and infection
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age ≥ 50 years
    2) Diagnosed COPD with forced expiratory volume in 1 second (FEV1) < 70 % of predicted
    3) Breathlessness relative to MRC dyspnoea grade 3 or more


    1) Alder ≥ 50 år
    2) Kendt med moderat, svær eller meget svær KOL iht. GOLD-kriterierne med forceret ekspiration i 1 sekund (FEV1) < 70 % af forventet
    3) Åndenød svarende til MRC dyspnøskala grad 3 eller højere
    E.4Principal exclusion criteria
    1) Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
    2) Patients with hyper- or hypocalcemia at inclusion
    3) Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator’s judgement
    4) Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent
    5) Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia
    6) Patients taking more than 20 µg vtamin D on a daily basis who do not have vitamin D (serum 25-OHD) less than 40 nnmol/L. If a patient takes vitamin D, dose should have been stable 6 months prior to inclusion in order to achieve steady-state.
    7) Pregnancy

    1) Patienter med kendte knoglemetaboliske sygdomme fraset knogleskørhed samt patienter med granulomatøse lidelser
    2) Patienter med for højt eller for lavt kalkindhold i blodet målt ved inklusion
    3) Patienter med hjerte-karlidelse eller lidelse i bevægeapparatet, der influerer væsentlig på gangfunktionen efter investigators skøn
    4) Patienter med demens eller andre mentale tilstande, der påvirker patientens evne til at underskrive et informeret samtykke og gennemføre et rehabiliteringsforløb
    5) Patienter med terminal tilstand eller kendt aktiv cancer med knoglemetastaser, der signifikant øger risikoen for forhøjet kalkindhold i blodet
    6) Patienter der indtager mere end 20 mikrogram D-vitamin dagligt, som ikke har 25-OHD mindre end 40 nmol/L. Hvis patienten tager D-vitamin, skal han/hun have taget dette i mindst 6 måneder inden inklusion
    7) Gravide
    E.5 End points
    E.5.1Primary end point(s)
    1) Withdrawal rate from pulmonary rehabilitation
    2) Walking distance assessed by ISWT and ESWT
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 weeks
    E.5.2Secondary end point(s)
    1) Vitamin D status: se-25-OHD, se-PTH
    2) Calcium metabolic status: se-calcium, se-fosfat and se-magnesium
    3) Quality of life (CAT og SGRQ)
    4) Bone metabolic status: Se-ICTP, -PINP and osteocalcin. BMD L1-L4 and BMD total hip (DXA-scan)
    5) Fat free mass and fat mass: DXA-scan
    6) Physical activity assessed by SenseWear Armband
    7) COPD excacerbations, all hospital admissions and death
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 11 weeks, 24 weeks and 52 weeks
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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
    Four weeks after the last visit of the last patient undergoing the trial. The patient is followed four weeks after he/she has taken the last tablet as a control of side effects.
    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 months5
    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.1.1Number 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state115
    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 with vitamin D deficiency or osteoporosis will be offered to be followed as outpatients at Hvidovre Hospital.
    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 Decision2011-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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