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    Summary
    EudraCT Number:2011-006163-22
    Sponsor's Protocol Code Number:PK-VIT-D
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-06
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-006163-22
    A.3Full title of the trial
    Study to evaluate the pharmacokinetic of vitamin D (cholecalciferol) in patients with obesity after bariatric surgery in vitamin D deficiency and after normalization
    Estudio para evaluar la farmacocinética de la vitamina D (colecalciferol) en pacientes intervenidos de cirugía de la obesidad en situación de déficit y tras normalización de la misma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the pharmacokinetic of vitamin D in patients with obesity after bariatric surgery
    Estudio para evaluar la farmacocinética de la vitamina D en pacientes intervenidos de cirugía de la obesidad
    A.4.1Sponsor's protocol code numberPK-VIT-D
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    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 supportNA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clínic de Barcelona
    B.5.2Functional name of contact pointVioleta Moize
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number349322754002326
    B.5.5Fax number34934516638
    B.5.6E-mailvmoize@clinic.ub.es
    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 VITAMIN D3 Kern Pharma
    D.2.1.1.2Name of the Marketing Authorisation holderKern Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Oral 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 8000055-64-3
    D.3.9.3Other descriptive nameVITAMIN D NOS
    D.3.9.4EV Substance CodeSUB15705MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.000 to 50.000
    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.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
    Obese patients after bariatric surgery
    Pacientes obesos intervenidos de cirugía bariátrica
    E.1.1.1Medical condition in easily understood language
    Obesity surgery
    Pacientes obesos intervenidos quirúrgicamente
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10059610
    E.1.2Term Obesity surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Establish vitamin D supplementation in obese patients after bariatric surgery.
    Establecer la pauta de suplementación de vitamina D en pacientes obesos intervenidos de cirugía de la obesidad en situación de déficit de vitamina D.
    E.2.2Secondary objectives of the trial
    -Evaluate the absorption of vitamin D
    -Compare the pharmacokinetics of vitamin D between bypass and tubular gastrectomy Bariatric Surgery
    - Evaluar la absorción de la vitamina D en estado de déficit
    - Comparar la farmacocinética de la vitamina D entre cirugía bariátrica por by-pass y por gastrectomía tubular
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 or more years old
    - with bariatric surgery in the last 18 months (+/- 6 months)
    - BMI: 25-33 kg/m2
    - vitamina D3 (OK)<20ng/mL.
    - Clinically stable, in the opinion of the investigator, at the time of inclusion
    - Signed consent form
    a. Pacientes de ambos sexos* de 18 o más años de edad.
    b. Intervenidos en los últimos 18 meses (+/- 6 meses) de cirugía bariátrica por by-pass o gastrectomía tubular.
    c. En situación de estabilización ponderal con un IMC estable entre 25-33kg/m2.
    d. Con niveles en suero de 25-hidroxi- vitamina D3 inferiores a 20ng/mL.
    e. Clínicamente estables, en opinión del investigador, en el momento de la inclusión.
    f. Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta
    E.4Principal exclusion criteria
    - pregnancy, lactation or intention during the study period.
    - menopause
    - GOP, GPT>2 UNL
    - glomerular filtration rate <60ml/min
    - previous renal lithiasis
    - any digestive disease to suggest malabsorption, granulomatous diseases, diabetic gastroenteropathy and taking medication likely to interfere with the absorption of vitamin D and bone metabolism such as corticosteroids and anticonvulsants
    - taking medication that interferes with calcium meabolism.
    - cholecalciferol hypersensitivity.
    - other bariatric surgery (different of by-pass or tubular gastrectomy)
    a. Embarazo, lactancia o previsión de embarazo durante el periodo de estudio.
    b. Mujeres menopáusicas.
    c. Enfermedad hepática (enzimas hepáticas 2 veces superior límite máximo de normalidad).
    d. Enfermedad renal (tasa de filtrado glomerular < 60 ml/min).
    e. Historia de litiasis renal
    f. Cualquier enfermedad digestiva que sugiera malabsorción, trastornos granulomatosos, gastroenteropatía diabética y toma de medicamentos susceptibles de interferir en la absorción de la vitamina D y del metabolismo del hueso. Corticoides, anticonvulsivantes
    g. Toma de medicación que interfiera con el metabolismo del calcio.
    h. Que presenta hipersensibilidad al colecalciferol
    i. Que se hayan realizado otra cirugía bariátrica que no sea BPG o GT.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokiteics parameters of vitamin D (AUC0-t, AUC0-?, Cmax y t1/2)
    Parámetros farmacocinéticos de la vitamina D (AUC0-t, AUC0-?, Cmax y t1/2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semanas
    E.5.2Secondary end point(s)
    - Comparison of vitamin D pharmacokinetic parameters between by-pass or tubular gastrectomy
    - Proportion of patients with secondary hyperparathyroidism
    - Change from baseline in urinary creatinine and calcium excretion
    - Change from baseline in total protein, albumin, phosphor, magnesium and serum calcium
    - Change from baseline in alkaline phosphatase
    - Change form baseline in distribution of body fat by DEXA
    - Change in treatment compliance
    - Incidence of adverse events
    - Proportion of patients with serious adverse events related with study medication.
    ? Comparación de los parámetros farmacocinéticos de la vitamina D de acuerdo a una aproximación no-compartimental (AUC0-t, AUC0-?, Cmax y t1/2) entre los dos tipos de cirugía (by-pass y gastrectomía tubular) a las 16 semanas de seguimiento.
    ? Proporción de pacientes con hiperparatiroidismo secundario en ambas cirugías a las 16 semanas.
    ? Cambio respecto al basal de los niveles de excreción urinaria de calcio y creatinina en ambas cirugías a las 16 semanas
    ? Cambio respecto al basal de los niveles de proteína total, albúmina, fósforo, magnesio y calcio sérico en ambas cirugías a las 16 semanas.
    ? Cambio respecto al basal de los niveles de fosfatasa alcalina en ambas cirugías a las 16 semanas.
    ? Cambio respecto al basal en la distribución de la grasa corporal mediante DEXA en cada una de las cirugías a las 16 semanas.
    ? Cambios de adherencia en ambas cirugías a las 16 semanas de tratamiento.
    ? Incidencia de acontecimientos adversos clínicos y de laboratorio para cada una de las cirugías a las 16 semanas.
    ? Proporción de pacientes con acontecimientos adversos graves relacionados con la medicación en estudio a las 16 semanas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semanas
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    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
    Last visit of the last subject
    Última visita del último paciente
    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 months0
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female No
    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 state44
    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)
    Expected normal treatment for that condition
    Tratamiento indicado para la condición
    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 Decision2012-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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