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    Summary
    EudraCT Number:2013-001948-60
    Sponsor's Protocol Code Number:DOSFEM
    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:2013-09-09
    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 number2013-001948-60
    A.3Full title of the trial
    Effects of high and low dose vitamin D on postprandial leukocyte activation, oxidative stress and vascular function in healthy overweight and obese females
    Effect van hoge en lage dosering vitamine D op postprandiale leukocyten activatie, oxidatieve stress en vaatfunctie in gezonde vrouwen met overgewicht en obesitas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The importance of vitamin D after a meal on inflammation and vascular function in women with vitamin D deficiency and overweight
    Het belang van vitamine D na de maaltijd op ontstekingsfactoren en vaatfunctie bij vrouwen met vitamine D tekort en overgewicht
    A.3.2Name or abbreviated title of the trial where available
    DOSFEM
    DOSFEM
    A.4.1Sponsor's protocol code numberDOSFEM
    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 SponsorSint Franciscus Gasthuis Rotterdam
    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 supportSint Franciscus Gasthuis
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSint Franciscus Gasthuis
    B.5.2Functional name of contact pointCenter for Diabetes and Vascular Me
    B.5.3 Address:
    B.5.3.1Street AddressKleiweg 500
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3045 PM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310104617267
    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 Cholecalciferol
    D.2.1.1.2Name of the Marketing Authorisation holderFormularium der Nederlandse Apothekers
    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 nameCholecalciferol
    D.3.4Pharmaceutical form Solution for use in drinking water
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    'healthy volunteers'
    'atherosclerosis'
    'vitamin D deficiency'
    'gezonde vrijwilligers'
    'atherosclerose'
    'vitamine D deficientie'
    E.1.1.1Medical condition in easily understood language
    hardening of the arteries
    vitamin D deficiency
    aderverkalking
    vitamine D tekort
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    The primary aim of this study is to investigate the effect of different doses of vitamin D on postprandial leukocyte activation marker CD11b
    Het primaire doel van de studie is het bestuderen van het effect van verschillende doseringen vitamine D op postprandiale leukocyt activatie marker CD11b
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to investigate the effect of different doses of vitamin D on postprandial leukocyte activation markers CD66b, CD35 and CD36, oxidative stress (lipoperoxidase) and vascular function (measured by arterial pulse wave velocity and augmentation index by pulse wave analysis)
    Secundaire doelen van de studie zijn het bestuderen van het effect van verschillende doseringen vitamine D op postprandiale leukocyt activatie marker CD66b, CD35 enCD36, oxidatieve stress (lipoperoxidase) en vaatfunctie (arterial pulse wave velocity en augmentation index door middel van pulse wave analysis)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age of 18 years or older
    Pre-menopausal
    BMI ≥25.0 kg/m2
    Vitamin D deficiency (defined by a 25-hydroxyvitamin D level of <30 ng/ml)
    Use of oral contraceptives
    Leeftijd van 18 jaar of ouder
    Pre-menopauzaal
    BMI ≥25.0 kg/m2
    Vitamine D deficientie (25-hydroxyvitamin D <30 ng/ml)
    Gebruik van orale anticonceptie
    E.4Principal exclusion criteria
    The use of any kind of medication except oral contraceptives
    Smoking
    Pregnancy
    Participation in a clinical trial less than 6 months before inclusion
    The use of (multi)vitamin supplements
    Het gebruik van medicatie anders dan orale anticonceptie
    Roken
    Zwangerschap
    Deelname aan een klinische trial minder dan 6 maanden voor inclusie
    Gebruik van (multi)vitamine supplementen
    E.5 End points
    E.5.1Primary end point(s)
    Effect of different vitamin D doses on postprandial leukocyte activation marker CD11b
    Effect van verschillende dosis vitamin D op postprandiale leukocyt activatie marker CD11b
    E.5.1.1Timepoint(s) of evaluation of this end point
    All of the end points will be determined within one week after the end of study
    Alle eindpunten worden binnen een week na het einde van de studie vastgelegd
    E.5.2Secondary end point(s)
    Effect of different vitamin D doses on postprandial leukocyte activation markers CD66b, CD35 and CD36, oxidative stress (lipoperoxidase) and vascular function (measured by arterial pulse wave velocity and augmentation index by pulse wave analysis)
    Effect van verschillende dosis vitamin D op postprandiale leukocyt activatie markers CD66b, CD35 en CD36, oxidatieve stress (lipoperoxidase) en vaatfunctie (gemeten met arteriele pulse wave velocity en augmentation index door pulse wave analysis)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All of the end points will be determined within one week after the end of study
    Alle eindpunten worden binnen een week na het einde van de studie vastgelegd
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    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 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 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) Yes
    E.8.2.2Placebo No
    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
    End of trial is defined as the last visit of the last subject undergoing the trial
    Het einde van de studie is gedefinieerd als het laatste bezoek van de laatste deelnemer aan de studie
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    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: 24
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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 state24
    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 further treatment or care after participation is foreseen. In case of persisting vitamin D deficiency or dyslipidemia the subject will be referred to the general practitioner for further treatment and follow-up.
    Na deelname aan de studie wordt geen verdere behandeling verwacht. In het geval van persisterende vitamine D deficientie of dyslipidemie wordt de deelnemer doorverwezen naar de huisarts voor verdere behandeling en follow-up.
    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 Decision2013-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-28
    P. End of Trial
    P.End of Trial StatusOngoing
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