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    Summary
    EudraCT Number:2019-000502-30
    Sponsor's Protocol Code Number:DKFZ-2019-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-000502-30
    A.3Full title of the trial
    Personalized Vitamin D Supplementation for Reducing or Preventing Fatigue and Enhancing Quality of Life of Patients with Colorectal Tumor:
    Randomized Intervention Trial
    Personalisierte Vitamin-D-Supplementation zur Reduzierung oder Prävention von Fatigue und zur Verbesserung der Lebensqualität bei Patienten mit Darmkrebs: Randomisierte Interventionsstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin D to improve Fatigue and Quality of Life in Patients with Colorectal Cancer
    Vitamin D zur Verbesserung der Müdigkeit und Lebensqualität bei Patienten mit Darmkrebs
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D for Reducing Cancer related Fatigue and Enhancing Quality of Life
    Vitamin D zur Verbesserung der krebsbedingten Müdigkeit und Lebensqualität
    A.4.1Sponsor's protocol code numberDKFZ-2019-001
    A.5.4Other Identifiers
    Name:Deutschen Register Klinischer Studien (DRKS)Number:DRKS00019907
    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 SponsorGerman Cancer Research Center (DKFZ)
    B.1.3.4CountryGermany
    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 supportWereld Kanker Onderzoek Fonds (WKOF) - World Cancer Research Fund International (WCRF)
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportGerman Cancer Research Center (DKFZ)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGerman Cancer Research Center (DKFZ)
    B.5.2Functional name of contact pointClinical Trial Office
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 280
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.6E-mailcto@dkfz-heidelberg.de
    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 Dekristol® 20 000 I.E. Weichkapseln
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule, hard
    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.3.9.3Other descriptive nameVitamin D3
    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 number20000
    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.IMP: 2
    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 Dekristol® 1000 I.E. Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule, hard
    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.3.9.3Other descriptive nameVitamin D3
    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 number2000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Fatigue in patients with colorectal cancer (ICD codes C18-C20 and C21.8) within 12 months after a colorectal cancer therapy (surgery, chemotherapy and/ or radiation) and not optimal vitamin D status
    Fatigue bei Patienten mit kolorektalen Karzinom (ICD-Codes C18-C20 und C21.8) und nicht optimaler Vitamin-D-Versorgung, bei denen die letzte Darmkrebstherapie (Operation, Chemotherapie und/ oder Bestrahlung) nicht länger als 12 Monaten zurück liegt.
    E.1.1.1Medical condition in easily understood language
    Exhaustion and pronounced tiredness in patients with colorectal cancer
    Erschöpfung und ausgeprägte Müdigkeit bei Patienten mit Darmkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10082239
    E.1.2Term Cancer fatigue
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062189
    E.1.2Term Vitamin D decreased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test whether the proposed personalized vitamin D3 dosing regimen reduces or prevents fatigue (primary outcome) among colorectal cancer patients with no optimal vitamin D status.
    Testen, ob eine personalisierte Vitamin-D3-Supplementation die Fatigue (primärer Endpunkt) bei Darmkrebspatienten mit Vitamin-D-Unterversorgung reduziert oder vorbeugt.
    E.2.2Secondary objectives of the trial
    To investigate the impact of a personalized vitamin D3 supplementation on the vitamin D status, the change of the fatigue score between baseline and follow-up, the fatigue domains (physical, emotional, and cognitive fatigue), quality of life, functional well-being, probable depression, infection frequency and other blood biomarkers (secondary endpoints).
    Untersuchen, inwiefern sich eine personalisierte Vitamin-D3-Supplementation auf den Vitamin D-Status, die Änderung des Fatigue-scores zwischen Baseline und Follow up, die Fatiguedomänen (physische, emotionale und kognitive Fatigue), die Lebensqualität, das funktionelle Wohlergehen, eine mögliche Depression, die Infektionshäufigkeit und verschiedene Krankheits-Biomarker auswirkt (sekundäre Endpunkte).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Colorectal cancer patients
    - Both men and women
    - Colorectal cancer therapy in last 12 months (surgical removal of tumor, radiation and/ or chemotherapy (adjuvant or neoadjuvant))
    - At least 3 weeks in-patient rehabilitation in a cooperating clinic is planned
    - Sufficient knowledge of the German language and mental capabilities to be able to give written informed consent and comply with the study requirements
    - Mindestens 18 Jahre alt
    - Darmkrebspatienten
    - Männer und Frauen
    - Darmkrebstherapie innerhalb der letzten 12 Monate (Entfernung des Tumors, Strahlung und/ oder Chemotherapie (adjuvant oder neoadjuvant))
    - Mindestens 3 Wochen stationäre Rehabilitation in einer kooperierenden Klinik (siehe Rekrutierungsstandorte)
    - Ausreichende Deutschkenntnisse und geistig-mentale Fähigkeiten, um selbstständig schriftlich in die Teilnahme einzuwilligen und die Studienanforderungen zu erfüllen
    E.4Principal exclusion criteria
    - Sufficient vitamin D status (25(OH)D > 60 nmol/L)
    - Severe renal impairment (eGFR < 30 ml/min/1,73 m²)
    - Hypercalcemia
    - Hypercalciuria
    - High-dose vitamin D3 therapy (≥ 2,000 IU daily or ≥ 14.000 IU weekly)
    - Therapy with vitamin D analogs (Vitamin D2 (Ergocalciferol), Dihydrotachysterol, Alfacalcidol, Calcitriol, or Calcifediol)
    - Topical therapy with vitamin D3 or vitamin D analogs
    - Hypersensitivity towards ingredients in Dekristol® 20 000/1000 I.E.: peanuts, soy, gelatin, lactose, maize starch or sucrose or ingredients in the placebo capsules (mannitol, silicon dioxide)
    - Nephrolithiasis with symptoms in the last year
    - Pseudohypoparathyreodism
    - Sarcoidosis
    - Therapy with cardiac glycosides
    - Therapy with high-dose calcium-supplements (> 1000 mg calcium daily)
    - Participation in another intervention trial
    - Pregnancy, planned pregnancy in next 12 weeks, or lactation
    - No use of adequate contraceptive measures in women of childbearing potential
    - Keine Vitamin-D-Unterversorgung (25(OH)D > 60 nmol/L)
    - Starke Niereninsuffizienz (eGFR < 30 ml/min/1,73 m²)
    - Hyperkalzämie
    - Hyperkalzurie
    - Vitamin D3-Therapie mit einer Dosis ≥ 2000 I.E./Tag oder einer äquivalenten Dosis (z. B. ≥ 14.000 I.E./Woche)
    - Therapie mit Vitamin D-Analoga (Vitamin D2 (Ergocalciferol), Dihydrotachysterol, Alfacalcidol, Calcitriol, oder Calcifediol)
    - Therapie mit topischen Vitamin D3 oder Vitamin D-analogen Präparaten
    - Überempfindlichkeit gegenüber Inhaltsstoffen in Dekristol® 20 000/1000 I.E. (Erdnüsse, Soja, Gelatine, Laktose, Maisstärke oder Saccharose) oder in Placebo-Kapseln (Mannitol, Siliciumdioxid)
    - Nierensteine, die im letzten Jahr symptomatisch waren
    - Pseudohypoparathyreodismus
    - Sarkoidose
    - Therapie mit Herzglykosiden
    - Therapie mit hochdosierten Kalziumpräparaten (> 1000mg / Tag)
    - Teilnahme an einer weiteren interventionellen Studie
    - Bestehende oder geplante Schwangerschaft in den nächsten 12 Wochen, Stillzeit
    - Keine geeigneten Verhütungsmaßnahmen bei Frauen im gebärfähigen Alter
    E.5 End points
    E.5.1Primary end point(s)
    Mean difference in FACIT-F fatigue subscale between intervention and placebo group. A mean difference ≥ 3 FACIT-F fatigue subscale points will be considered a clinically relevant difference.
    Mittlere Differenz in der FACIT-F-fatigue-Subscale zwischen Interventions- und Placebogruppe; klinisch relevant, wenn mittlere Differenz ≥ 3 Punkte in der FACIT-F-Fatigue-Subscale beträgt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 13 to 16
    Woche 13 bis 16
    E.5.2Secondary end point(s)
    - Mean difference in change of FACIT-F fatigue subscale from baseline to trial week 13-16 between intervention and placebo group. A mean difference ≥ 3 FACIT-F fatigue subscale points will be considered a clinically relevant difference

    - Mean differences in EORTC-FA12 physical, emotional and cognitive fatigue scores between intervention and placebo group as well as mean differences in changes in these scores from baseline to trial week 13-16 between intervention and placebo group.

    - Mean difference in GDS-15 scale between intervention and placebo group as well as mean difference in changes in this scale from baseline to trial week 13-16 between intervention and placebo group.

    - Mean difference in FACIT-F functional well-being (FWB) score between intervention and placebo group as well as mean difference in changes in this score from baseline to trial week 13-16 between intervention and placebo group.

    - Mean differences in overall and domain specific quality of life scores of the EORTC QLQ-C30 questionnaire between intervention and placebo group as well as mean differences in changes in these scores from baseline to trial week 13-16 between intervention and placebo group. Mean differences ≥ 5 points in the overall and domain specific scores of the EORTC QLQ-C30 will be considered clinically relevant differences.

    - Mean differences in infection frequencies (total, upper respiratory and lower respiratory tract infections) between intervention and placebo group.

    - Mean difference in levels of total serum 25(OH)D between intervention and placebo group as well as mean difference in change of levels of total serum 25(OH)D from baseline to trial day 12-21 and from baseline to trial week 13-16.

    - Mean serum 25(OH)D levels > 60 nmol/L in intervention group.

    - Mean differences in levels of disease biomarkers (including white blood cell count (WBC), leukocyte subtype counts (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, serum CRP, systematic inflammatory response scores, serum uric acid, serum total cholesterol, serum LDL cholesterol, serum HDL cholesterol, and serum triglycerides) between intervention and placebo group as well as mean difference in change of levels of these biomarkers from baseline to trial day 12-21 and from baseline to trial week 13-16.

    - Mean difference in HbA1c levels between intervention and placebo group as well as mean difference in change of HbA1c levels from baseline to trial week 13-16

    - Differences in frequency of safety parameters (including hypervitaminosis D, hypercalcemia, hypercalciuria and renal dysfunction (eGFR < 30 ml/min/1.73 m2)) between intervention and placebo group

    - Mean differences in levels of safety parameters (including albumin-corrected serum calcium and urine calcium/creatinine ratio, and eGFR) between intervention and placebo group
    - Mittlere Differenz in der Veränderung der FACIT-F-Fatigue-Subskala von Baseline bis Studienwoche 13-16 zwischen Interventions- und Placebogruppe. Ein mittlerer Unterschied ≥ 3 FACIT-F-Fatigue-Subskalenpunkte wird als klinisch relevanter Unterschied betrachtet.

    - Mittlere Differenz des EORTC-FA12-Scores für physische, emotionale und kognitive Müdigkeit zwischen der Interventions- und der Placebogruppe sowie mittlere Differenz in der Veränderung dieses Scores von Baseline bis Studienwoche 13-16 zwischen der Interventions- und der Placebogruppe.

    - Mittlere Differenz der GDS-15-Skala zwischen Interventions- und Placebogruppe sowie mittlere Differenz in der Veränderung der GDS-15-Skala von Baseline bis Studienwoche 13-16 zwischen Interventions- und Placebogruppe.

    - Mittlere Differenz des FACIT-F-Scores des funktionellen Wohlbefindens zwischen Interventions- und Placebogruppe sowie mittlere Differenz in der Veränderung dieses Scores von Baseline bis Studienwoche 13-16 zwischen Interventions- und Placebogruppe.

    - Mittlere Differenz des Scores der allgemeinen und domänenspezifischen Lebensqualität im EORTC QLQ-C30 Fragebogen zwischen Interventions- und Placebogruppe sowie mittlere Differenz in der Veränderung dieses Scores von Baseline bis Studienwoche 13-16 zwischen Interventions- und Placebogruppe. Mittlere Unterschiede ≥ 5 Punkte in den EORTC QLQ-C30-Scores werden als klinisch relevante Unterschiede betrachtet.

    - Mittlere Differenz der Infektionshäufigkeit (Gesamtanzahl sowie Anzahl der Infektionen der oberen und unteren Atemwege) zwischen Interventions- und Placebogruppe.

    - Mittlere Differenz des Gesamtserum-25-hydroxyvitamin-D-Spiegels zwischen Interventions- und Placebogruppe sowie mittlere Differenz in der Veränderung des Gesamtserum-25-hydroxyvitamin-D-Spiegels von Baseline zum Studientag 12-21 und von Baseline zur Studienwoche 13-16.

    - Mittlere Serum-25(OH)D-Spiegel > 60 nmol/L in der Interventionsgruppe.

    - Mittlere Differenz der Werte der Krankheitsbiomarker (einschließlich Anzahl der weißen Blutkörperchen, Leukozyten-Subtyp-Zahlen (neutrophile, eosinophile, basophile Granulozyten, Lymphozyten und Monozyten), Thrombozytenzahl, Serum-CRP, Scores für systematische Entzündungsreaktionen, Serum-Harnsäure, Serum-Gesamtcholesterin, Serum-LDL-Cholesterin, Serum-HDL-Cholesterin und Serum-Triglyzeride) zwischen Interventions- und Placebogruppe sowie mittlere Differenz in den Veränderungen dieser Werte von Baseline zum Studientag 12-21 und von Baseline bis Studienwoche 13-16.

    - Mittlere Differenz der HbA1c-Werte zwischen Interventions- und Placebogruppe sowie mittlere Differenz in der Veränderung dieses Wertes von Baseline bis Studienwoche 13-16.

    - Unterschied in der Häufigkeit von Sicherheitsparametern (einschließlich Hypervitaminose D, Hyperkalziämie, Hyperkalziurie, Nierenfunktionsstörung (eGFR < 30 ml/min/1.73 m2)) zwischen Interventions- und Placebogruppe.

    - Mittlere Differenz der Werte von Sicherheitsparametern (einschließlich Albumin-korrigierte Serumkalziumspiegel, Höhe des Urin-Kalzium/Kreatinin-Verhältnisses und eGFR) zwischen Interventions- und Placebogruppe.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 12 to 21:
    - Vitamin D status (total serum 25(OH)D Level, mean serum 25(OH)D levels > 60 nmol/L)
    - Disease biomarkers (except HbA1c)
    - Safety parameters (hypervitaminosis D, hypercalcemia, hypercalciuria, urine calcium/creatinine Ratio, eGFR)

    Week 13 to 16:
    - Fatigue (FACIT-F fatigue subscale, EORTC-FA12)
    - Possible Depression
    - Functional well-being
    - Overall and domain specific quality of life
    - Infection frequency (total, upper respiratory and lower respiratory tract infections)
    - Vitamin D status (total serum 25(OH)D Level, mean serum 25(OH)D levels > 60 nmol/L)
    - Disease biomarkers (including HbA1c)
    - Safety parameters (hypervitaminosis D, hypercalcemia, hypercalciuria, urine calcium/creatinine Ratio, eGFR)
    Tag 12 bis 21:
    - Vitamin D Status (Gesamtspiegel von 25-Hydroxyvitamin D (25(OH)D), mittlere Serum-25(OH)D-Spiegel > 60 nmol/L)
    - Krankheitsbiomarker (exkl. HbA1c)
    - Sicherheitsparameter (Hypervitaminose D, Hyperkalziämie, Hyperkalziurie, Urin-Kalzium/Kreatinin-Verhältnis, eGFR)
    Woche 13 bis 16:
    - Fatigue (FACIT-F-fatigue-Subscale, EORTC-FA12)
    - Mögliche Depressionen
    - Funktionelles Wohlbefinden
    - Gesamte und domänenspezifische Lebensqualität
    - Infektionshäufigkeit (Gesamtanzahl sowie Anzahl der Infektionen der oberen und unteren Atemwege)
    - Vitamin D Status (Gesamtspiegel von 25(OH)D, mittlere Serum-25(OH)D-Spiegel > 60 nmol/L)
    - Krankheitsbiomarker (inkl. HbA1c)
    - Sicherheitsparameter (Hypervitaminose D, Hyperkalziämie, Hyperkalziurie, Urin-Kalzium/Kreatinin-Verhältnis, eGFR)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) 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 No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    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
    Final contact with last subject.
    Finaler Kontakt mit letztem Patienten.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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: 156
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state456
    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)
    After the end of the trial has been reported for a participant, the study participant will be unblinded immediately by receiving a letter containing information on the treatment. The letter will contain the results of the latest 25(OH)D measurement and information about options to treat vitamin D deficiency. The participants can take the letter to their general practitioners and will decide together whether to start (for placebo group) or continue (for verum group) vitamin D supplementation.
    Am Ende der Studie wird der Studienteilnehmer sofort durch einen Brief mit Informationen über die Behandlung entblindet. Der Brief enthält die Ergebnisse der letzten 25(OH)D-Messung und Informationen über Möglichkeiten zur Behandlung des Vitamin-D-Mangels. Die Teilnehmer können den Brief zu ihrem Hausarzt mitnehmen und entscheiden gemeinsam, ob sie mit der Vitamin-D-Supplementierung beginnen (bei der Placebo-Gruppe) oder sie fortsetzen (bei der Verum-Gruppe).
    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 Decision2020-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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