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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2014-000047-33
    Sponsor's Protocol Code Number:VitD-EX1.0
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-02-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-000047-33
    A.3Full title of the trial
    The effect of high-resistance muscle strength training and vitamin D
    supplementation in persons with knee osteoarthritis
    Het effect van hoog-intensieve spierkrachttraining en vitamine D suppletie
    bij mensen met knieartrose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of intensive muscle strength training and vitamin D supplements
    in persons with knee osteoarthritis
    Het effect van intensieve spierkrachttraining en extra vitamine D suppletie
    bij mensen met knieartrose
    A.3.2Name or abbreviated title of the trial where available
    vitD-EX
    vitD-EX
    A.4.1Sponsor's protocol code numberVitD-EX1.0
    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 SponsorVU University Medical Centre
    B.1.3.4CountryNetherlands
    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 supportReumafonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReade
    B.5.2Functional name of contact pointTrial coordinator
    B.5.3 Address:
    B.5.3.1Street Addressdr. Jan van Breemenstraat
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1056AB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031(0)205896291
    B.5.5Fax number0031(0)205896316
    B.5.6E-mailm.vd.leeden@reade.nl
    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 Devaron
    D.2.1.1.2Name of the Marketing Authorisation holderVemedia Manufacturing BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDevaron
    D.3.2Product code Vitamin D
    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.3.9.2Current sponsor codeVitamin D
    D.3.9.3Other descriptive nameCOLECALCIFEROL
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 Yes
    D.3.11.13.1Other medicinal product typevitamin
    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
    knee osteoarthritis
    vitamin D deficiency
    knieartrose
    vitamine D deficientie
    E.1.1.1Medical condition in easily understood language
    cartilage wear of knee joint
    low vitamin D level
    kraakbeenschade aan het kniegewricht
    laag vitamine D gehalte
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 determine (1) whether high-resistance strength training (70-80% of one-repetition maximum (1RM)) is more effective in improving muscle strength compared to low-resistance strength training (20-30% of 1RM) and (2) whether vitamin D supplementation enhances the effect of muscle strength training on muscle strength in knee OA patients with vitamin D deficiency.
    The ultimate goal of the intervention study is to optimize strength training in knee OA, thereby increasing the beneficial effect on pain and activity limitations.
    (1) Bepalen of hoog-intensieve krachttraining (op 70-80% van het maximum) effectiever is om spierkracht te verbeteren dan laag-intensieve krachttraining (op 20-30% van het maximum).
    (2) Bepalen of vitamine D supplementen het effect van spierkrachttraining op spierkracht versterken.
    Het uiteindelijke doel van deze interventiestudie is het optimaliseren van de effecten van spierkrachttraining voor patiënten met knieartrose.
    E.2.2Secondary objectives of the trial
    To determine (1) whether high-resistance strength training (70-80% of one-repetition maximum (1RM)) is more effective in improving knee pain, activity limitations, inflammatory markers, falls and fractures, self-reported knee instability and depressive and anxious mood compared to low-resistance strength training (20-30% of 1RM) and (2) whether vitamin D supplementation enhances the effect of muscle strength training on knee pain, activity limitations, inflammatory markers, falls and fractures, self-reported knee instability and depressive and anxious mood.


    (1) Bepalen of hoog-intensieve krachttraining (op 70-80% van het maximum) effectiever is om kniepijn, beperkingen in activiteiten, ontstekingsmarkers, vallen en fracturen, zelfgerapporteerde knie-instabiliteit en depressieve en angstige gevoelens te verbeteren dan laag-intensieve krachttraining (op 20-30% van het maximum).
    (2) Bepalen of vitamine D supplementen het effect van spierkrachttraining versterken op: kniepijn, beperkingen in activiteiten, ontstekingsmarkers, vallen en fracturen, zelfgerapporteerde knie-instabiliteit en depressieve en angstige gevoelens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Knee pain and at least 2 of the following 5 items: morning stiffness < 30 minutes, crepitations, bone sensitivity, bony enlargement of the joint margin, no palpable warmth
    - Age ≥ 55 and ≤ 80 years
    - Vitamin D deficiency: 25(OH)D level >15nmol/L and <50 nmol/L (in winter) or <70nmol/L (in summer)
    - kniepijn en tenminste 2 van de volgende 5 items: ochtendstijfheid , 30 minuten, crepitaties, bontgevoeligheid, botvergroting van de rand van de gewrichtsspleet, geen palpabele warmte
    - leeftijd ≥55 en ≤80 jaar
    - vitamine D deficiëntie: 25(OH)D niveau >15nmol/L en <50nmol/L (in de winter) of <70nmol/L (in de zomer)
    E.4Principal exclusion criteria
    - Other forms of arthritis than OA
    - Absolute contra-indication for exercise therapy/strength training
    - Inability to perform strength training program due to severe co-morbidity
    - Use of vitamin D supplements >400 IU daily
    - Living in a nursing home
    -
    - andere vormen van artritis dan atrose
    - absolute contra-indicatie voor oefentherapie/krachttraining
    - ernstige comorbiditeit
    - gebruik van vitamine D supplementen >400 ie dagelijks
    - woonachtig in een verzorging- of verpleeghuis
    E.5 End points
    E.5.1Primary end point(s)
    change in (isokinetic) muscle strength of quadriceps en hamstrings muscles
    verandering in (isokinetische) spierkracht van quadriceps en hamstrings
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 and 12 months
    6 en 12 maanden
    E.5.2Secondary end point(s)
    Change in: knee pain, activity limitations (self-report and performance based), inflammatory markers (i.e. C-reactive protein and Erythrocyte Sedimentation Rate), falls and fractures, self-reported knee instability, depression and anxiety. Global perceived effect.
    Verandering in: kniepijn, beperkingen in activiteiten, inflammatiemarkers, vallen en fracturen, zelfgerapporteerde knie-instabiliteit en depressie en angst. Zelf ervaren herstel
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months
    6 en 12 maanden
    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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    vitamin D versus placebo: double blind, high versus low resistance training: single blind
    2x2 factorial design in 220 patients with knee OA and vitamin D deficiency
    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 trial4
    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
    LVLS
    laatste meting van laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state220
    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
    Geen
    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 Decision2014-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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