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    Clinical Trial Results:
    Effects of Vitamin D supplementation on Vitamin D levels and immune activation in HIV infected individuals on antiretroviral therapy-A pilot study.

    Summary
    EudraCT number
    		 2010-022775-57
    Trial protocol
    		 GB  
    Global end of trial date
    10 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2018
    First version publication date
    14 Oct 2018
    Other versions
    Summary report(s)
    		 Publication
    FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    JF002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Dr Julie Fox, Guy's and St Thomas' NHS Foundation Trust, 0044 0207188 7188, julie.fox@kcl.ac.uk
    Scientific contact
    Dr Julie Fox, Guy's and St Thomas' NHS Foundation Trust, 0044 0207188 7188, julie.fox@kcl.ac.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
    10 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigate the role vitamin D supplementation on restoring vitamin D levels in HIV infected individuals on antiretroviral therapy.
    Protection of trial subjects
    Safety blood tests (FBC, Urea and electrolytes and liver function tests) and adherence review are incorporated into the visit schedule.
    Background therapy
    		 All participants must be receiving antiretroviral therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from one clinical site in London UK between November 2011 and April 2014.

    Pre-assignment
    Screening details
    		 Having given consent, participants will undergo screening assessments to determine whether they are eligible to participate in the study according to the inclusion/exclusion criteria. The following evaluations will be performed during Screening: Review of inclusion/exclusion criteria PIS and Written Informed Consent Conmed review Directed Physical

    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
    Participants will be randomised on a 1:1 basis with randomisation/allocation to study arm

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vit D
    Arm description
    		 At baseline participants will be randomized to receive vitamin D supplements for 48w.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adcal D3 Lemon Chewable Tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Adcal D3® lemon flavoured chewable tablet: 2 tablets daily

    Arm title
    		 No Vit D
    Arm description
    		 Standard care with no added intervention
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Vit D No Vit D
    Started
    15
    15
    Completed
    15
    14
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 30 30
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 44 (30 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Vit D
    Reporting group description
    		 At baseline participants will be randomized to receive vitamin D supplements for 48w.

    Reporting group title
    No Vit D
    Reporting group description
    		 Standard care with no added intervention

    Primary: Clinical Endpoint

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    End point title
    		 Clinical Endpoint [1]
    End point description
    The primary outcome is the mean change in 25 (OH) D level at 48 weeks from baseline in each arm
    End point type
    Primary
    End point timeframe
    48 weeks from baseline
    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: Please see attached report for results and statistical analysis.
    End point values
    		 Vit D No Vit D
    Number of subjects analysed
    15
    14
    Units: ug/L
        arithmetic mean (standard error)
    -5.2 ( 0 )
    0.2 ( 0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Duration of trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Vit D
    Reporting group description
    		 Intervention of Vitamin D

    Reporting group title
    No Vit D
    Reporting group description
    		 Control group without intervention

    Serious adverse events
    		 Vit D No Vit D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Initiation of Duranavir/Ritonavir
    Additional description: Overnight hospital admission for initiation of Duranavir/Ritonavir treatment
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture left Mandibular condyle
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Vit D No Vit D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 15 (93.33%)
    14 / 15 (93.33%)
    Investigations
    Increased glucose levels
    Additional description: Increased glucose levels secondary to Duranavir
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Left shoulder operation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Burning sensation /numbness knee and thigh
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Cluster headache
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Migraine
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Numbness of fingers
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Accidental exposure
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Fever
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Loss of appetite
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Skin rash and cellulitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Cervical /sub mandibular lymph node inflammation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hayfever
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Eye disorders
    Blurred Vision
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation, Jaundice, vomiting
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Common cold
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Coryzal runny nose
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Coryzal symptoms
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 15 (13.33%)
         occurrences all number
    3
    2
    Cough with frothy white sputum
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Dry cough
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Dry cough at night
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Head cold
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    LRTI and flu like symptoms
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Right ring finger rash
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Skin rash
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Osteoporosis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Right calf pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Painful ankle
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Painful ankles
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Painful shoulder
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Athletes foot
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Candida Balantis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Ear Infection
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Eye Infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Mouth Abscess
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Vaginal Thrush
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Anaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Dec 2011
    Changes to the inclusion/exclusion criteria. The change of visit 5 from a clinic visit to a telephone visit. This is to more accurately reflect current medical practice for visit schedule. The lab test for CRP has been removed throughout the protocol and the method of randomisation has been changed.

    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.
    None reported
    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.

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