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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2010-024460-18
    Sponsor's Protocol Code Number:VIDI2
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2010-024460-18
    A.3Full title of the trial
    Vitamin-D-deficiency in imigrants. Treatment study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin-D-brist bland invandrare. Behandlingsstudien
    A.3.2Name or abbreviated title of the trial where available
    VIDI 2
    A.4.1Sponsor's protocol code numberVIDI2
    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 SponsorUmeå Universitet
    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 supportVästerbottens läns landsting
    B.4.1Name of organisation providing supportVisare Norr de fyra norra landstingen
    B.4.1Name of organisation providing supportALF medel, Västerbottens läns landsting
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUmeå Universitet
    B.5.2Functional name of contact pointMargareta Norberg
    B.5.3 Address:
    B.5.3.1Street AddressUmeå Universitet, Epidemiologi och global hälsa
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post code901 87
    B.5.4Telephone number+46907853343
    B.5.5Fax number+4690138977
    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. name Vitamin D3 forte Renapharma, 0,5 mg/ml
    D. of the Marketing Authorisation holderRenapharma AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameVitamin D3 forte Renapharma, 0,5 mg/ml
    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.3.9.1CAS number 67-97-0
    D.3.9.4EV Substance CodeSUB06794MIG
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D-vitaminbrist, D-vitamin insufficiens och suboptimala D-vitaminnivåer
    E.1.1.1Medical condition in easily understood language
    D-vitaminbrist, D-vitamin insufficiens och suboptimala D-vitaminnivåer
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10046242
    E.1.2Term Unspecified vitamin D deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Studera effekten av olika doser av D-vitaminsubstitution till personer med lågt S-D3.
    I första hand analyseras effekten på biokemiska variabler (S-D3 och S-PTH).
    E.2.2Secondary objectives of the trial
    Analysera effekten av olika doser av D-vitaminsubstitution på subjektiva besvär och symtom relaterade till D-vitaminbrist och D-vitamininsufficiens
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • S-D-vitaminnivå < 75 nmol/L
    • Män och kvinnor
    • Ålder 25-65 år
    • Född i Mellanöstern eller Afrika och boende i Umeå med omnejd.
    E.4Principal exclusion criteria
    1. Allergi mot cholekalciferol, kokosolja, palmkärneolja och gummi.
    2. S-D3 > 75nmol/L
    3. Hypercalcemi: Albuminkorrigerat S-kalcium ≥ 2.65 mmol/L.
    4. Njurfunktionsnedsättning: S-kreatinin > 130 mmol/L.
    5. Anamnes på njursten.
    6. Nefrocalcinos.
    7. Anamnes på sarcoidos och andra granulomatösa sjukdomar.
    8. Känd malign sjukdom.
    9. Pågående läkemedelsbehandling med phenytoin, barbiturater, rifampicin, isoniazid.
    10. Pågående läkemedelsbehandling med Hjärtglukosider (Digoxin, Lanoxin)
    11. Pågående läkemedelsbehandling med Tiazider (Salures, Esidrex, Hydroklortiazid, Centyl-K, Metolazon)
    12. Pågående läkemedelsbehandling med Etalpha, Rocaltrol, Ergokalciferol, Dygratyl.
    13. Pågående behandling med läkemedel som påverkar fettabsorbtionen; Orlistat, Colestyramin.
    14. Pågående oral behandling med glukokorticoider (kortisonpreparat)
    15. Pågående behandling med aluminiumhaltiga medel (Gaviscon, Link, Novaluzid, Novalucol, Rennie) och som inte kan utsättas, se punkt 13.4.3.
    16. Pågående behandling med preparat innehållande Omega-3, D-vitamin och/eller kalcium och som inte kan utsättas, se punkt 13.4.3.
    17. Immobilisering.
    18. Övrigt medicinskt tillstånd som omöjliggör deltagande i studien (bedöms av ansvarig forskare).
    19. Graviditet hos kvinna som har S-D3<25nmol/L (dvs D-vitaminbrist).
    20. Ammande kvinna
    E.5 End points
    E.5.1Primary end point(s)
    Att analysera effekten av behandlingsalternativen på biokemiska variabler (S-D3 och S-PTH).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 veckor efter behandlingsstart.
    E.5.2Secondary end point(s)
    Sekundära mål är att utvärdera effekten på symptom relaterade till D-vitaminbrist; uppmätt muskelstyrka och balans, muskulära besvär och smärta enligt CRF, depressiva symptom (HAD) och livskvalitet (EQ5D) och självskattad hälsa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 veckor efter behandlingsstart.
    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 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. 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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    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 state150
    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)
    Personer med S-D3 <25 nmol/L vid sista testet skrives remiss till Medicinska kliniken.
    SP med S-D3 25-49 nmol/L vid sista testet erbjuds remiss till primärvården.
    SP med S-D3 50-74 nmol/L vid sista testet informeras och rekommenderas att vintertid ta D-vitaminsupplement.
    SP med S-D3 ≥75 nmol/L informeras om optimala värden och rekommenderas att vintertid ta D-vitaminsupplement
    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 Decision2011-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-01
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