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    Summary
    EudraCT Number:2014-002766-73
    Sponsor's Protocol Code Number:PHT/2014/44
    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:2015-09-02
    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 number2014-002766-73
    A.3Full title of the trial
    The effect of oral Vitamin D supplementation on endothelial function, vascular inflammation, oxidative stress and insulin sensitivity in patients with impaired fasting glucose: A randomised, double blinded, placebo controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of Vitamin D on cardiovascular risk in patients with impaired fasting glucose
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D supplementation in impaired fasting glycaemia
    A.4.1Sponsor's protocol code numberPHT/2014/44
    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 SponsorPortsmouth Hospitals NHS Trust
    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 supportPortsmouth Hospitals NHS Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAcademic Department of Diabetes and Endocrinology, Queen Alexandra Hospital, Portsmouth
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportUniversity of Portsmouth
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportInternis Pharmaceuticals Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPortsmouth Hospitals NHS Trust
    B.5.2Functional name of contact pointChristine Bevan
    B.5.3 Address:
    B.5.3.1Street AddressR&D Department, 1st Floor Gloucester House, Queen Alexandra Hospital
    B.5.3.2Town/ cityPortsmouth
    B.5.3.3Post codePO6 3LY
    B.5.4Telephone number02392285212
    B.5.5Fax number02392286037
    B.5.6E-mailchristine.bevan@porthosp.nhs.uk
    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 Fultium-D3 3,200 IU capsule
    D.2.1.1.2Name of the Marketing Authorisation holderInternis Pharmaceuticals Ltd, Carradine House, 237 Regents Park Road, London, N3 3LF
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFultium D3 3,200IU (Colecalciferol)
    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 INNColecalciferol
    D.3.9.1CAS number 67-97-0
    D.3.9.3Other descriptive nameVitamin D3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3200
    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
    Impaired fasting glycaemia
    E.1.1.1Medical condition in easily understood language
    Impaired fasting glycaemia-A state when body's ability to process blood glucose is impaired resulting in higher fasting morning blood glucose levels compared to levels expected in healthy individuals.
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10046242
    E.1.2Term Unspecified vitamin D deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10056997
    E.1.2Term Impaired fasting glucose
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to examine whether Vitamin D3 3,200 IU supplementation in patients with impaired fasting glucose has an effect on:

    Reduction of the VCAM-1 marker (vascular circulating adhesion molecule-1) in blood. VCAM-1 molecule is released to blood circulation when endothelium of the blood vessels is activated by harmful chemicals (oxidative stress and inflammation).
    E.2.2Secondary objectives of the trial
    The secondary objective is to examine whether Vitamin D3 3,200 IU supplementation in patients with impaired fasting glucose has positive effect on:

    1. Reducing the levels of inflammation markers in the circulation
    2. Improvement of body's ability to use insulin more efficiently (insulin sensitivity)
    3. Reducing the production of harmful chemicals that damage the body (oxidative stress)
    4. Improvement of levels of blood fats (cholesterol, triglycerides) and HbA1c

    We also aim to examine in sub-analysis whether there are any differences in the above parameters in vitamin D deficient and Vitamin D sufficient participants
    and to examine the associations between insulin resistance, endothelial function, oxidative stress and vascular inflammation at baseline and after intervention.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Individual with a diagnosis of impaired fasting glucose (fasting glucose 6.1-6.9 mmol/l as per WHO criteria)
    • Age 18 to 75 years inclusive
    • Participant is willing and able to give informed consent for participation in the study
    E.4Principal exclusion criteria
    • Established cardiovascular disease (ischaemic heart disease, cerebrovascular disease and peripheral vascular disease)
    • Individuals with chronic kidney disease (stage 3B- eGFR 30-44 ml/min/1.73 m2 , stage 4- eGFR 15-29 ml/min/1.73 m2 and stage 5- eGFR <15 ml/min/1.73 m2)
    • Individuals with fat malabsorption- cystic fibrosis, celiac disease, Crohn’s disease, acute or chronic pancreatitis (risk of malabsorption of Vitamin D)
    • Steroids therapy (increases Vitamin D metabolism and elimination)
    • On medications that can increase metabolism of vitamin D (phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampicin, non-nucleoside reverse transcriptase inhibitors used in HIV)
    • Primary hyperparathyroidism
    • Active granulomatous diseases including sarcoidosis and tuberculosis (increased activity of 1 alfa hydroxylase within granulomas can potentially lead to increased vitamin D toxicity)
    • Allergy to vitamin D preparations, nitrates (GTN), beta2 agonists (salbutamol)
    • Already taking vitamin D or calcium supplements
    • On thiazide diuretics (can reduce renal excretion of calcium and increase risk of hypercalcaemia)
    • On cardiac glycosides (hypercalcaemia can potentiate cardiac glycosides toxicity)
    • On metformin
    • Renal stones
    • Peanut and soya allergy
    • Pregnant and intention of becoming pregnant
    • Breastfeeding
    • Unable to give consent
    • Participation in other clinical trials
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome measure of the study is the relative change (=Absolute change on logarithmic scale) in VCAM-1 (marker of endothelial activation) folowing administration of Vitamin D3 versus placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    VCAM-1 marker will be measured in blood at participant's first study visit. Participants will then take 3,200IU of Colecalciferol daily for 12 weeks (84 days). Following this intervention participants will return for their final visit and a blood test for VCAM-1 marker will be repeated.
    E.5.2Secondary end point(s)
    Secondary end points are:
    • Change in insulin sensitivity (HOMA-B method)
    • Change in markers of oxidative stress (TAOS, LHP, 8-iso-Prostaglandin F2a Activity, cGMP, GSH/GSSG)
    • Change in markers of vascular inflammation (hsCRP and ACR)
    • Change in reflection index of the digital volume waveform after inhalation of salbutamol using finger photoplethysmography
    • Change in metabolic markers (total cholesterol, LDL and HDL cholesterol, triglycerides, HbA1c)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At first study visit a blood sample is taken from intravenous line for:
    0 min – glucose, insulin, lipids, 25(OH)D3, HbA1c
    5 min – glucose and insulin only
    10 min – glucose and insulin plus VCAM-1, LHP, cGMP, GSH/GSSG/, TAOS, hsCRP, 8-iso- Prostaglandin F2a Activity
    From 3 insulin and glucose values (taken 5 minutes apart) insulin sensitivity is calculated using HOMA-B method.
    Following blood sampling participants undergo painless measurement of endothelium dependent vasodilatation using finger photoplethysmography. Urine sample is taken for ACR. Following their first study visit participants will take 3,200IU of Colecalciferol daily for 12 weeks (84 days). Following this intervention participants will return for their final study visit and all the above tests vill be repeated.
    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 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 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 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.
    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 months9
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 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 state80
    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)
    Vitamin D3 (colecalciferol) will not be supplied to participants at the end of the study. Potential participants will be made aware of this in the participant information sheet (PIS). Participants who wish to ensure that their Vitamin D levels are adequate will receive advice on healthy diet, healthy exposure to natural sunshine and available lower dose Vitamin D supplements that can be purchased from health food stores.
    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 Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-23
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