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    Summary
    EudraCT Number:2015-003910-26
    Sponsor's Protocol Code Number:01/2015
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-10
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2015-003910-26
    A.3Full title of the trial
    Fase II, unicenter, open, randomized trial to evaluate the response of Th17 and T regulatory lymphocytes to 24 weeks supplementation with cholecalciferol in patients with arterial hypertension, obesity and vitamin D deficiency.
    Ensaio clínico de fase II, unicêntrico, aberto e randomizado para avaliar a resposta das células T helper 17 e T reguladoras à suplementação com colecalciferol durante 24 semanas em doentes com hipertensão arterial, obesidade e défice de vitamina D.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of cholecalciferol supplementation in peripheral blood leucocytes in patients with arterial hypertension, obesity and vitamin D deficiency.
    Efeitos da suplementação com colecalciferol nos leucócitos do sangue periférico em doentes com hipertensão arterial, obesidade e défice de vitamina D.
    A.4.1Sponsor's protocol code number01/2015
    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 SponsorNúcleo de Estudos de Hipertensão da Beira Interior
    B.1.3.4CountryPortugal
    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 supportNúcleo de Estudos de Hipertensão da Beira Interior
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNúcleo de Estudos de Hipertensão da Beira Interior
    B.5.2Functional name of contact pointErnesto Rocha
    B.5.3 Address:
    B.5.3.1Street AddressUnidade Local de Saúde de Castelo Branco, E.P.E., Avenida Pedro Álvares Cabral
    B.5.3.2Town/ cityCastelo Branco
    B.5.3.3Post code6000-085
    B.5.3.4CountryPortugal
    B.5.4Telephone number351272000233
    B.5.5Fax number351272000269
    B.5.6E-mailnucleo.estudos.hipertensao@gmail.com
    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 Deltius
    D.2.1.1.2Name of the Marketing Authorisation holderItalfarmaco
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 liquid
    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 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
    Obesity associated arterial hypertension
    Metabolic syndrome associated arterial hypertension
    Hipertensão arterial associada à obesidade
    Hipertensão arterial associada à síndroma metabólica
    E.1.1.1Medical condition in easily understood language
    Arterial hypertension
    Obesity
    Metabolic syndrome
    Hipertensão arterial
    obesidade
    síndroma metabólica
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    Compare the percentage of TCD4+, TCD8+, Th17 and T regulatory cells in the serum of hypertensive patients with obesity and/or metabolic syndrome (O/MS) associated hypertension before and after 24 weeks of cholecalciferol supplementation.
    Comparar percentagem de linfócitos TCD4+, TCD8+, Th17 e Tregs no soro de doentes com HTA associada a obesidade e/ou síndroma metabólica (O/SM) antes e após 24 semanas de suplementação com colecalciferol.
    E.2.2Secondary objectives of the trial
    1. Compare the metabolic profile (glutamine and glutamate concentrations) in the serum of hypertensive patients with O/MS associated hypertension before and after 24 weeks of cholecalciferol supplementation.

    2. Compare the percentage of macrophages and T limphocytes in subcutaneous abdominal adipose tissue of hypertensive patients with O/MS associated hypertension before and after 24 weeks of cholecalciferol supplementation.

    3. Compare insulin-resistance indexes (HbA1c and visceral adiposity index) of hypertensive patients with O/MS associated hypertension before and after 24 weeks of cholecalciferol supplementation.

    4. Characterize cardiac index, systemic vascular resistance index and thoracic fluid content in the patients studied before cholecalciferol supplementation.

    5. Quantify salt consumption in the diet and correlate with Th17 and T regulatory cells percentage in the patients studied before cholecalciferol supplementation.
    1. Comparar o perfil metabólico sérico (concentrações de glutamina e glutamato) dos doentes com O/SM antes e após 24 semanas de suplementação com colecalciferol.
    2. Comparar a percentagem de macrófagos e células T residentes no tecido adiposo abdominal subcutâneo antes e após 24 semanas de suplementação com colecalciferol.
    3. Comparar índices de insulino-resistência (HbA1c e índice de adiposidade visceral) antes e após 24 semanas de suplementação com colecalciferol.
    4. Caracterizar parâmetros hemodinâmicos dos doentes com HTA associada a O/SM antes do início de colecalciferol.
    5. Quantificar consumo de sal na dieta e correlacioná-lo com a percentagem de células Th17 e células T reguladoras.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Obtention of free and informed consent to participate, dated and signed by the participant
    - Free willing and availability to participate in the all course of the trial as well as to accomplish with all the procedures of the trial protocol
    - Hability to take autonomously oral medication and capacity to adhere to the therapeutic scheme proposed by the trial
    - In women of child-bearing potential use of efficacious contraception
    - Age between 45-65 years
    - Treated essential hypertension (systolic blood pressure ¿ 159 mmHg and diastolic blood pressure ¿ 99 mmHg)
    - Obesity (body mass index ¿ 30 Kg/m2) or metabolic syndrome by the International Diabetes Federation criteria
    - Obtenção de consentimento informado, livre e esclarecido, assinado e datado pelo doente
    - Vontade expressa e disponibilidade do doente para participar ao longo de toda a duração do ensaio clínico assim como para cumprir com os procedimentos descritos no protocolo
    - Capacidade para tomar medicação por via oral e demonstração de capacidade para aderir ao regime terapêutico proposto
    - Idade entre 45-65 anos
    - Em mulheres em idade fértil utilização obrigatória de método contracetivo eficaz
    - História de HTA essencial tratada (PA sistólica ¿ 159 mmHg e PA diastólica ¿ 99 mmHg)
    - Obesidade (índice de massa corporal ¿30 Kg/m2) ou síndroma metabólica pelos critérios da Federação Internacional de Diabetes
    E.4Principal exclusion criteria
    - Actual or previous medication with modulatores of the immune system (e.g. steroids, immunossupressive medication)
    - Actual treatment with antihistamines
    - Autoimmmune disease
    - Sarcoidosis
    - Active infectious or neoplasic disease
    - Other chronic infectious or inflammatory diseases (e.g. tuberculosis, diabetic foot, chronic viral hepatitis)
    - Glomerular filtration rate < 60 mL/min/1,73m2
    - Vitamin D in plasma VD ¿ 30 ng/mL
    - Serum calcium > 10.5 mg/dL
    - Kidney stones or nephrocalcinosis
    - Active smoker
    - Active treatment with cholecalciferol before the beggining of the trial
    - Pregnacy, breastfeeding or non-utilization of efficacious contraceptive method
    - Intolerance to cholecalciferol
    - Simultaneous participation in another trial
    - Medicação atual ou anterior com imunomoduladores (p.e corticóides, fármacos imunossupressores)
    - Medicação atual com anti-histamínicos
    - Doenças autoimunes
    - Sarcoidose
    - Doenças infeciosas ou neoplásicas ativas
    - Outros processos infeciosos ou inflamatórios crónicos (por exemplo: tuberculose, pé diabético, hepatite viral crónica)
    - Taxa de filtração glomerular < 60 mL/min/1,73m2
    - Doseamento de VD ¿ 30 ng/mL
    - Cálcio sérico > 10.5 mg/dL
    - Litíase renal ou nefrocalcinose
    - Status de fumador ativo
    - Terapêutica atual com colecalciferol antes do início do estudo
    - Gravidez, amamentação ou não utilização de método anticonceptivos
    - Intolerância ao colecalciferol
    - Participação simultânea noutro ensaio clínico
    E.5 End points
    E.5.1Primary end point(s)
    Frequency of TCD4+, TCD8+, Th17 and T regulatory cells before and after 24 weeks of cholecalciferol supplemmentation.
    Frequência de linfócitos TCD4+, TCD8+, Th17 e Tregs antes e após 24 semanas de suplementação com colecalciferol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint for evaluation of the defined end point is 24 weeks after the beginning of cholecalciferol supplementation.
    A avaliação do endpoint definido será feita 24 semanas após o início da suplementação com colecalciferol.
    E.5.2Secondary end point(s)
    - Frequency of T limphocytes and macrophages in the subcutaneous abdominal adipose tissue before and after 24 weeks cholecalciferol supplementation.
    - Variation of metabolic profiles (glutamine and glutamate) before and after 24 weeks cholecalciferol supplementation.
    - Variation of insulin-resistance indexes (HbA1c and visceral adiposity index) before and after 24 weeks cholecalciferol supplementation.
    - Frequência de linfócitos T e macrófagos no tecido adiposo subcutâneo abdominal antes e após suplementação com colecalciferol.
    - Variação dos espectros metabólicos (concentração de glutamina e glutamato) antes e após colecalciferol.
    - Variação dos índices de insulino-resistência (HbA1c e índice de adiposidade visceral) antes e após suplementação com colecalciferol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoint for evaluation of the defined end points is 24 weeks after the beginning of cholecalciferol supplementation.
    24 semanas após o início de colecalciferol.
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Medicação anti-hipertensora habitual.
    Usual anti-hypertensive medication.
    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
    LVLS
    Última visita do último doente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    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 state30
    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.
    Patients will keep normal treatment for their medical condition.
    Nenhum.
    Os doentes manterão tratamento médico habitual.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-31
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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