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    Summary
    EudraCT Number:2011-005763-24
    Sponsor's Protocol Code Number:CTSUBEST-D
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-005763-24
    A.3Full title of the trial
    BEST-D (Biochemical efficacy and safety trial of vitamin D): a dose-finding trial assessing biochemical and vascular effects of high dose vitamin D
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BEST-D: A trial to identify the best suitable oral daily dose of vitamin D supplement required to optimise blood levels
    A.3.2Name or abbreviated title of the trial where available
    BEST-D: Biochemical Efficacy and Safety Trial of Vitamin D(V1.0)
    A.4.1Sponsor's protocol code numberCTSUBEST-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 SponsorUniversity of Oxford
    B.1.3.4CountryUnited Kingdom
    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 supportClinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford
    B.4.2CountryUnited Kingdom
    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 No
    D.2.1.1.1Trade name Cholecalciferol (Vitamin D3)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCholecalciferol
    D.3.4Pharmaceutical form Capsule, soft
    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 INNCholecalciferol
    D.3.9.1CAS number 67-97-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS3
    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, soft
    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
    BEST-D is a trial assessing the efficacy and safety of vitamin D3 supplements (two doses 50μg and 100μg); hence there are no specific medical conditions under study. Volunteers aged 65 years or older who may or may not have other diseases will be included (except those specifically excluded).
    E.1.1.1Medical condition in easily understood language
    Metabolism and nutrition, vitamin related, vitamin deficiency, hypovitaminosis, vitamin depletion.
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10047630
    E.1.2Term Vitamin depletion
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to determine the optimal safe and effective dose of vitamin D to test in a large scale trial in older people and compare the biochemical effects on blood levels of vitamin D and parathyroid hormone of 100 mcg or 50 mcg or placebo when administered daily for one year.
    E.2.2Secondary objectives of the trial
    The study will also assess the effects of supplementation with vitamin D (100mcg/day or 50mcg/day or placebo) on markers of bone health, muscle strength, blood pressure and arterial stiffness, blood lipids and biomarkers of inflammation and immune function.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible for enrolment in the study if they are:

    • Age ≥ 65 years
    • Living in the community
    • Ambulatory
    E.4Principal exclusion criteria
    The GP will screen the practice records for all patients aged 65 years or greater who are living in the community to check for the following exclusion criteria using a screening questionnaire. In addition, the study nurse will check the exclusion criteria directly with all potential participants at their initial study visit.

    Exclusion criteria
    • Nursing home residents
    • Regular use of vitamin D supplements with >400 IU (10 mcg) vitamin D daily
    • Use of alendronate, risedronate, zoledronic acid, parathyroid hormone, or calcitonin
    • Medically diagnosed dementia
    • History of hypercalcaemia, hyperparathyroidism, lymphoma, sarcoidosis, active tuberculosis
    • History of renal calculus
    • Known to be poorly compliant with clinic visits or with taking medication
    • Recent history of alcohol or substance misuse or abuse
    • Medical history that might limit the ability to take the study
    treatment for the duration of the study (e.g. terminal illness)
    • Regular prescribed calcium supplements.
    E.5 End points
    E.5.1Primary end point(s)
    1. The primary efficacy assessment will involve an “intention-to-treat” analysis among all randomized subjects of the effects of vitamin D3 100mcg daily vs vitamin D3 50mcg daily on the proportion of individuals with levels of 25(OH)D above 90 nmol/L at the end of the study.

    2. A co-primary endpoint will be the difference between those allocated 100 vs 50 µg daily in the mean 25(OH)D levels at the scheduled study end.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All endpoints will be evaluated at the end of 1 year.
    E.5.2Secondary end point(s)
    (i) Mean blood levels of 25(OH)D during follow-up.
    (ii) The proportions of participants with blood 25(OH)D levels >90 nmol/L at the 6 and 12 month visits.
    (iii) The proportion of participants with PTH levels suppressed into the normal range at the 6 and 12 month visits.
    (iv) The proportion of participants with calcium levels above the normal range at the 6 and 12 month visits.
    (v) Other laboratory tests of safety: phosphate, albumin, creatinine, alkaline phosphatase.
    (vi) The changes from baseline in hsCRP, creatinine, nBNP, inflammatory cytokines (e.g. IL5, IL6, IL1β, IFNγ and TNFα) and mRNA expression, and markers of innate immunity at 6 and 12 month visits.
    (vii) The difference in the change from baseline in diastolic and systolic blood pressure, heart rate and arterial stiffness at 6 and 12 months.
    (viii) The difference in the changes from baseline in total cholesterol, LDL-C, HDL-C, triglycerides, apo-B and apo-A at 12 months.
    (ix) The rates of upper respiratory tract infection during follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood analyses on the pharmacokinetics of vitamin D and related bone markers will be assessed at the end of 1 month, 6 months and 12 months of treatment.

    Effects on inflammation, cardiovascular function and inflammation will be assessed at 6 and 12 months of treatment.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Effects on bones, inflammation, and vascular function.
    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.8.2.3.1Comparator description
    A different dose of Vitamin D3
    E.8.2.4Number of treatment arms in the trial3
    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.8.5.1Number of sites anticipated in the EEA1
    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
    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 months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    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 Yes
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    As the present trial is a dose-finding, efficacy and safety trial, it lacks the statistical...
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Wellcome Trust Centre for Human Genetics
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-10
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