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    Clinical Trial Results:
    Effect of active vitamin-D treatment on left ventricular hypertrophy in patients with type-2 diabetes and stage-3 chronic kidney disease.

    Summary
    EudraCT number
    		 2011-003025-10
    Trial protocol
    		 GB  
    Global end of trial date
    22 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Apr 2025
    First version publication date
    30 Apr 2025
    Other versions
    Summary report(s)
    		 VIVID Report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VIVID
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Dr Luigi Gnudi, King's College London, +44 02078484413, luigi.gnudi@kcl.ac.uk
    Scientific contact
    Dr Luigi Gnudi, King's College London, +44 02078484413, luigi.gnudi@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Dr Luigi Gnudi, Guy's and St Thomas NHS Foundation Trust, +44 02078484413, luigi.gnudi@kcl.ac.uk
    Scientific contact
    Dr Luigi Gnudi, Guy's and St Thomas NHS Foundation Trust, +44 02078484413, luigi.gnudi@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
    08 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main research question is to evaluate the effect of Calcitriol treatment as compared to placebo on left ventricular mass in patients with type 2 diabetes, left ventricular hyperthrophy and chronic kidney disease. Left ventricular hypertrophy is a marker and predictor of cardiovascular disease risk. Left ventricular mass will be assessed by magnetic resonance imaging. Interventions that reduce left ventricular hypertrophy may prevent cardiovascular disease. Currently it is not known if treatment with Calcitriol can affect left ventricular mass in patients with diabetes, left ventricular hypertrophy and kidney disease. We wish to study the effect of Calcitriol or placebo as add on treatment to existing medical treatments on left ventricular mass in a placebo controlled double blind study. Patients will continue with other medical treatments for their diabetes and kidney disease.
    Protection of trial subjects
    Every patient has the right to discontinue study participation, and any patient could be discontinued from the study for any reason beneficial to his/her well-being . If a patient is lost to follow-up, every possible effort will be made to contact the patient to obtain visit information and the unused study drug. As per good clinical practice, alternative therapy will be offered to all patients who discontinued prematurely from the study. If discontinuation was due to significant adverse events, the patient will be followed by the investigator or his/her designee to satisfactory conclusion. Patients discontinued after randomization due to clinically significant abnormalities in laboratory values will be followed until the abnormality resolved, or abnormality judged to be permanent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2012
    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: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    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)
    18
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 71 [1]
    Number of subjects completed
    		 45

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 screen failure: 16
    Reason: Number of subjects
    		 lost to follow up: 7
    Reason: Number of subjects
    		 Adverse event, serious fatal: 1
    Reason: Number of subjects
    		 Protocol deviation: 2
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We do not count screened participants as enrolled.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Calcitriol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calcitriol
    Investigational medicinal product code
    Other name
    Rocaltrol
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.5 mcg once daily of calcitriol for 48 weeks.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Gelatin Capsule filled with Mycrocristalline cellulose and magnesium stearate. Once daily for 48 weeks.

    Number of subjects in period 1 [2]
    		Calcitriol Placebo
    Started
    19
    26
    Completed
    19
    26
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We do not count screened participants as enrolled.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Calcitriol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Calcitriol Placebo Total
    Number of subjects
    		 19 26 45
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.32 ( 8.3 ) 64.31 ( 9.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 7 12
        Male
    		 14 19 33

    End points

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    End points reporting groups
    Reporting group title
    Calcitriol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: LVMI

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    End point title
    		 LVMI [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to visit 11 (week 48)
    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 uploaded report
    End point values
    		 Calcitriol Placebo
    Number of subjects analysed
    19
    26
    Units: g/m2
    arithmetic mean (standard deviation)
        baseline
    45.42 ( 11.64 )
    48.14 ( 14.16 )
        visit 11
    44.86 ( 11.48 )
    48.85 ( 11.63 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to week 48
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Calcitriol
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Calcitriol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 26 (26.92%)
    5 / 19 (26.32%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Injury, poisoning and procedural complications
    Fall - Acute Kidney Injury
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UTI - Acute Kidney Injury
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall secondary to chronic leg pain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Heart Failure
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    NSTEMI
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Heart Disease
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decompensated Heart Failure
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive heart failure with acute exacerbation
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stroke
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea, feeling unwell
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Shortness of Breath
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Community Acquired Pneumonia - Gout
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CAP and COPD
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and Soft Tissue Infection
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Overload
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Overload and Haemolysis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Calcitriol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 26 (73.08%)
    17 / 19 (89.47%)
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Surgical and medical procedures
    Left big toe surgery
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Left knee replacement
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Right eye cataract surgery
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Vitrectomy
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Aspecific pain to legs and arms
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Bilateral pretibial oedema
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Chest Pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Flu-like symptoms
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 19 (10.53%)
         occurrences all number
    2
    2
    Intermittent Chest Pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Left calf swelling
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Lower limb oedema
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Progressively worsening pitting oedema left calf
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Tiredness
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Immune system disorders
    Hay Fever
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Breathlessness (SOB)
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 19 (5.26%)
         occurrences all number
    4
    1
    Nasal Congestion
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Low Mood
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Psychiatric Disorder
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Sleeplessness
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 26 (19.23%)
    1 / 19 (5.26%)
         occurrences all number
    5
    1
    First Degree burn left hand
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Inflamed first right toe
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Left Ankle sprain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Left fifth finger fracture
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Trauma to left hand
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Heart Failure
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nervous system disorders
    Aphasic Episodes
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Intermittent Headaches
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Neuropathic pain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Prickly sensation to hands and feet
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Changed taste
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Eye disorders
    Bilateral cataracts
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    itchy, sore watery eyes
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Right vitreous haemorrhage
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    Episode of right upper quadrant abdominal pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Cutaneous aspecific eruption
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Diabetic Foot Ulcer
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Eczema patches to left leg and arm
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Dry Skin Face
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Itchiness
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Rash on Legs
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Right foot heel ulcer
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Sweating
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Upper back sebaceous cyst
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Raised urea, renal impairment
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Renal function decline
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Stinging pain after urination
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Hand osteoarthritis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Back Pain/ Sciatica
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Frozen shoulder
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Left shoulder pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    MSK Pain (Ankle)
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    MSK pain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Neck Pain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Pain in left first finger
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Pain in right lower rib cage
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Right ankle swelling
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Right leg pain on walking
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Swollen Joint
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Tightness to both arms and legs
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Hand Arthritis (Hand)
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Infections and infestations
    Candidiasis of the oesophagus
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Chest Infection
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Cold Symptoms
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Diabetic Foot Infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Genital Thrush
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Gum Infection
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Inflammation of right urinary tract with pain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Left Leg Cellulitis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Sepsis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Soft tissue infection
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Upper airway (respiratory tract) infection
         subjects affected / exposed
    3 / 26 (11.54%)
    5 / 19 (26.32%)
         occurrences all number
    3
    6
    Urinary Tract Infection
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 19 (5.26%)
         occurrences all number
    3
    2
    Urosepsis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Osteoarthritis knees
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Osteoarthritis knee
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Episodes of Hypoglycaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Fluid Overload
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Gout
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 19 (15.79%)
         occurrences all number
    1
    3
    Hypoglycaemia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Feb 2012
    Protocol Version 2.0 IMP Labeling
    14 Nov 2013
    Protocol version 4 - updated inclusion criteria
    10 Jun 2014
    Protocol version 5.0 1. The addition of a sub study to investigate new exploratory endpoints; patients who consent to the sub-study will attend St. George's Hospital for two additional study visits. 2. Inclusion criteria has been amended to include: A history of elevated urinary albumin excretion rate, patient compliance will be recorded at visit seven and eight, and minor typographical errors.
    31 Mar 2015
    Protocol Version 6.0
    28 Feb 2018
    Protocol Version 8.0
    27 Jun 2019
    RSI SmPC Rocaltrol 0.5/0.25mcg capsules update

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36934979
    For support, Contact us.
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    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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