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   43865   clinical trials with a EudraCT protocol, of which   7286   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

    Download PDF

    Clinical Trial Results:
    Can Vitamin D Replacement Reduce Insulin resistance In South Asians with Vitamin D Deficiency?

    Summary
    EudraCT number
    		 2010-024213-31
    Trial protocol
    		 GB  
    Global end of trial date
    08 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2020
    First version publication date
    01 Jul 2020
    Other versions
    Summary report(s)
    		 File note

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    UNOLE0166
    Additional study identifiers
    ISRCTN number
    		 ISRCTN18522562
    US NCT number
    		 NCT01385345
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leicester
    Sponsor organisation address
    Research Governance Office, Academic Department, Leicester General Hospital, Leicester, United Kingdom, LE5 4PW
    Public contact
    Professor Melanie Davies, University of Leicester, +44 01162586481, melanie.davies@uhl-tr.nhs.uk
    Scientific contact
    Professor Melanie Davies, University of Leicester, +44 01162586481, melanie.davies@uhl-tr.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The principal objective of this study is to assess whether giving 6 months of high dose Vitamin D3 (200,000 units or 100,000 units once every six to eight weeks) oral liquid drops together with daily maintenance Vitamin D3 1000 units tablets in south Asians with low vitamin D (25OH vitamin D3 <25nmol/l) improves markers of insulin function (specifically a marker known as HOMA1-IR, by greater than 0.36 units) compared to south Asians with low Vitamin D levels who take just maintenance 1000 units Vitamin D3 per day.
    Protection of trial subjects
    N/A - trial ended prematurely
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Only 3 participants were randomized prior to the study being terminated. No data analysis was carried out (due to lack of data) and there have been no study publications. MHRA confirmed that the study is exempt to posting results on 24.05.2019

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Vitamin D3
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vitamin D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage would have been 100,000 units

    Number of subjects in period 1
    		Vitamin D3
    Started
    99999
    Completed
    99999

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Vitamin D3
    Reporting group description
    		 -

    Primary: Reduction in insulin resistance

    		 Close Top of page
    End point title
    		 Reduction in insulin resistance [1]
    End point description
    End point type
    Primary
    End point timeframe
    N/A
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only 3 participants were randomised prior to the study being terminated. Insufficient data was generated and therefore no analysis has been performed. No results are available for this study.
    End point values
    		 Vitamin D3
    Number of subjects analysed
    99999
    Units: n/a
    99999
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of study were to be collected.
    Adverse event reporting additional description
    N/A
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only 3 participants were randomised prior to the study being terminated. No SAEs were reported prior to termination of the study.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Only 3 participants were randomized prior to the study being terminated. No data analysis was carried out (due to lack of data) and there have been no study publications. MHRA confirmed that the study is exempt to posting results on 24.05.2019.
    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-Sun Apr 28 08:36:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA