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    Clinical Trial Results:
    Controlled, randomized, four-arm comparative, open label, multi-centric trial to compare the efficacy and safety parameters of the once-a-week or once-a-month administered 7000 IU, or 30000 IU vitamin D (cholecalciferol) to a 1000 IU dosage applied daily in vitamin D deficient patients

    Summary
    EudraCT number
    2012-005232-29
    Trial protocol
    HU  
    Global end of trial date
    11 Dec 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Oct 2021
    First version publication date
    23 Oct 2021
    Other versions
    Summary report(s)
    Clinical Study Summary PAT12-730DS

    Trial information

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    Trial identification
    Sponsor protocol code
    PAT12-730DS
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pharma Patent Kft.
    Sponsor organisation address
    Szentlászlói út 44., Szentendre, Hungary, 2000
    Public contact
    Iroda-törzskönyvezés, Pharma Patent Kft, +36 1630 6182, clinical@pharmapatent.hu
    Scientific contact
    Iroda-törzskönyvezés, Pharma Patent Kft, +36 1630 6182, clinical@pharmapatent.hu
    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
    14 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison efficacy by 25OHD and safety parameters of a daily single dose of 1000 IU to a once-a week or once-a month administered 7000 IU or 30000 IU vitamin D, respectively.
    Protection of trial subjects
    Specific measures were not needed. The only intervention during the course of study was blood sample collection. Patients were informed in details about the possible side effect and all the contacts of the medical support.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Feb 2013
    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
    Hungary: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    70
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    D vitamin level <20ng/ml, Lab tests for 25(OH)D, seCa, PTH, Urine analysis, Lab blood test and routine chemistry. Screened 140 subjects, 89 enrolled. Main reason for exclusion: high D vitamine level.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group "A"
    Arm description
    1000 IU kolekalciferol (Vitamin D3), 1000 IU once a day, per os
    Arm type
    Active comparator

    Investigational medicinal product name
    1000 IU kolekalciferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 IU once a day, per os

    Arm title
    Group "B"
    Arm description
    7000 IU kolekalciferol (Vitamin D3), 7000 IU once a week, per os
    Arm type
    Active comparator

    Investigational medicinal product name
    7000 IU kolekalciferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    7000 IU once a week, per os

    Arm title
    Group "C"
    Arm description
    30000 IU kolekalciferol (Vitamin D3), 30000 IU once a month, per os
    Arm type
    Active comparator

    Investigational medicinal product name
    30000 IU kolekalciferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30000 IU once a month, per os

    Investigational medicinal product name
    30000 IU kolekalciferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30000 IU once a week, per os

    Arm title
    Group "D"
    Arm description
    30000 IU kolekalciferol (Vitamin D3), 30000 IU once a week, per os
    Arm type
    Active comparator

    Investigational medicinal product name
    30000 IU kolekalciferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30000 IU once a week, per os

    Number of subjects in period 1
    Group "A" Group "B" Group "C" Group "D"
    Started
    22
    23
    22
    22
    Completed
    21
    20
    20
    21
    Not completed
    1
    3
    2
    1
         Consent withdrawn by subject
    -
    1
    2
    1
         Lost to follow-up
    1
    2
    -
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Group "A"
    Reporting group description
    1000 IU kolekalciferol (Vitamin D3), 1000 IU once a day, per os

    Reporting group title
    Group "B"
    Reporting group description
    7000 IU kolekalciferol (Vitamin D3), 7000 IU once a week, per os

    Reporting group title
    Group "C"
    Reporting group description
    30000 IU kolekalciferol (Vitamin D3), 30000 IU once a month, per os

    Reporting group title
    Group "D"
    Reporting group description
    30000 IU kolekalciferol (Vitamin D3), 30000 IU once a week, per os

    Primary: Changes in 25(OH)D versus to baseline in each group

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    End point title
    Changes in 25(OH)D versus to baseline in each group
    End point description
    End point type
    Primary
    End point timeframe
    90 days
    End point values
    Group "A" Group "B" Group "C" Group "D"
    Number of subjects analysed
    21
    20
    20
    21
    Units: ng/ml
    21
    20
    20
    21
    Statistical analysis title
    ANOVA
    Statistical analysis description
    ANOVA and paired test of Dunnett.
    Comparison groups
    Group "B" v Group "C" v Group "D" v Group "A"
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    ≤ 0.05
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    27
         upper limit
    30
    Notes
    [1] - 1. and 2. groups comparison level 81.5% 1. and 3. groups comparison level 80.6% 1. and 4. groups comparison level 99.5%

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Recording of sign of adverse event were done by each visit and in between visit by the phone follow-up visits.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    D group
    Reporting group description
    -

    Reporting group title
    A group
    Reporting group description
    -

    Reporting group title
    B group
    Reporting group description
    -

    Reporting group title
    C group
    Reporting group description
    -

    Serious adverse events
    D group A group B group C group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    D group A group B group C group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 22 (9.09%)
    3 / 22 (13.64%)
    5 / 23 (21.74%)
    1 / 22 (4.55%)
    Endocrine disorders
    Laboratory disorder
         subjects affected / exposed
    2 / 22 (9.09%)
    3 / 22 (13.64%)
    5 / 23 (21.74%)
    1 / 22 (4.55%)
         occurrences all number
    2
    3
    5
    1

    More information

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    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.
    None reported
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