Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-002113-21
    Sponsor's Protocol Code Number:0822-009
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-17
    Trial results View 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 number2005-002113-21
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter 16 Week Study to Assess the Effect of Vitamin D3 8400 IU Once Weekly on Body Sway and Neuromuscular Function in Men and Women Over 70 Years Old
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D Proof of Concept Study
    A.4.1Sponsor's protocol code number0822-009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck & Co. Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.3Other descriptive namecholecalciferol, (5Z, 7E)-9,10-secocholesta-5,7,10(19)-trien-3β-ol, activated 7-dehydrocholesterol,
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8400
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboTablet
    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
    Vitamin D deficiency, unspecified
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10047626
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare change in mediolateral body sway (measured with eyes open using the AccuSwayPLUS platform) following administration of vitamin D3 8400 IU once-weekly for 16 weeks to that following administration of placebo in men and women over 70 years old.
    E.2.2Secondary objectives of the trial
    In men and women over 70 years old: (1) To evaluate the safety and tolerability of vitamin D3 8400 IU administered once-weekly for 16 weeks relative to placebo. (2) To compare the change in functional status assessed using the Short Physical Performance Battery (SPPB) following administration of vitamin D3 8400 IU once-weekly for 16 weeks to placebo. (3) To evaluate the mean serum 25-hydroxyvitamin D [25(OH)D], calcium, and phosphate levels following administration of vitamin D3 8400 IU once-weekly for 16 weeks relative to placebo. (4) If the response to treatment with vitamin D3 is not universal across subjects, to determine the baseline serum 25(OH)D concentration in the subgroup of subjects in whom body sway improved in response to 16 weeks treatment with vitamin D3 8400 IU.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Subject is a man or a woman aged ≥ 70 years at the time of consent.
    • Subject is judged to be in satisfactory health based on medical history, physical examination, and laboratory screening evaluation.
    • Subject is willing and able to limit direct sunlight exposure during the course of the study and to apply sunscreen (SPF 15 or greater) to exposed skin if anticipating exposure to direct sunlight for a period of time exceeding 15 minutes at any time.
    Note: sunbathing and tanning salons will be prohibited.
    • The subject is ambulatory and can walk 10 feet without a walking aid.
    • The subject has a serum 25(OH)D level ≥ 6 ng/mL but ≤ 20 ng/mL at screening (Visit 1).
    • If the subject has a serum 25(OH) D level ≥ 6 ng/mL but ≤ 9 ng/mL at screening (Visit 1), he/she does not have:
    i. 24-hour urine calcium levels < 50 mg/24 hours
    ii. Elevated bone-specific alkaline phosphatase levels
    • Subject is mentally competent - has scored > 24 on the Folstein's State Examination (MMSE) at screening (Visit 1)."
    E.4Principal exclusion criteria
    General
    • Subject has any form of neurological impairments that would preclude accurate determination of sway or SPPB tests, such as but not limited to Parkinson’s disease, essential tremors, seizures, and muscular dystrophy.
    • Subject has a significant end-organ disease, i.e. genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, psychiatric, or pulmonary disease which, in the opinion of the investigator or SPONSOR, may pose an added risk to the subject or impair the subject’s ability to complete the trial or confound the results.
    • Subject has a physical impairment that prevents him/her from undergoing evaluations required in the protocol.
    • Subject has had a myocardial infarction within 6 months of the screening visit (Visit 1).
    • Subject has uncontrolled hypertension (i.e. sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg).
    Note: This criterion allows for the adjustment of the subject’s medication. However, stability in the antihypertensive therapy must be achieved for a subject to be eligible for the study.
    • Subject has a history of any form of cancer, with the following exceptions:
    i. Adequately treated superficial basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
    ii. Solid tumor definitively treated without any history of recurrence for at least 5 years prior to screening (Visit 1).
    iii. Breast cancer ≤ Stage II and tumor size < 3 cm, not locally invasive or with lymph node involvement at the time of surgery.
    • Subject has malabsorption syndrome.
    • Subject has primary hyperparathyroidism (i.e. hypercalcemia and elevated PTH) or active thyroid disease, as demonstrated by abnormal serum TSH (measured with an ultra-sensitive assay) and Free T4 at screening (Visit 1).
    Note: If the subject is receiving thyroid hormone replacement, the dose must not have been changed within 3 months of the screening visit (Visit 1).
    • Subject has a history or evidence of impaired renal function, defined as a serum creatinine value ≥ 2.0 mg/dL.
    • Subject has had osteomalacia within 12 months of the screening visit (Visit 1).
    • Subject has postural hypotension.
    • Subject has peripheral neuropathy.
    Medications
    • The subject is unwilling to refrain from the use of any dietary supplements (other than those supplied by the study) that contain substantial amounts of vitamin D (i.e. >100 IU/day) for the total duration of the study, including the placebo run-in phase. These include fortified juices, multivitamins, and fish oil supplements or other animal extracts.
    Note: Use of other vitamins (such as vitamin A, vitamin B series, and vitamin C) and of minerals is permitted in the study. Subjects may also consume milk or fish.
    • Subject is currently receiving or previously received treatment with any of the following agents:
    o Treatment with vitamin D in excess of 800 IU/day at screening (Visit 1), or within 6 months of the screening visit (Visit 1).
    o Treatment with any active metabolites of vitamin D at screening (Visit 1), or within 6 months of the screening visit (Visit 1); (e.g. 1,25(OH)2 D3 [calcitriol] or 1-alpha-hydroxyvitamin D3 [alfacalcidol]).
    o Treatment with anabolic steroids (including testosterone) or oral glucocorticoids at screening (Visit 1), or within 12 months of to the screening visit (Visit 1).
    o Treatment with growth hormone at screening (Visit 1), or within 12 months of the screening visit (Visit 1).
    o Treatment with any drug that may interfere with postural stability and body sway, such as benzodiazepines and muscle relaxants at screening (Visit 1).
    o Treatment with any drug that may affect vitamin D metabolism such as anticonvulsants and daily use of cimetidine at screening (Visit 1).
    Note: Use of cimitidine is allowed if taken weekly or less frequently.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be body sway. Other endpoints include SPPB, and serum 25(OH)D, calcium, and phosphate levels.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    There are no stopping rules for this trial.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 216
    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)
    it is not different from the expected normal treatment of that condition
    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 Decision2005-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-07-18
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 18:01:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA