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ID

14501

Description

Orthomolecular Therapy and Asthma in Children; ODM derived from: https://clinicaltrials.gov/show/NCT00672529

Link

https://clinicaltrials.gov/show/NCT00672529

Keywords

Versions (1)
  1. 4/19/16 4/19/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 19, 2016

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Creative Commons BY-NC 3.0
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    Eligibility Asthma NCT00672529

    English

    Eligibility Asthma NCT00672529

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00672529
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    male or female aged 7 to 18 years
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    mild to moderate asthma diagnosed by a respirologist
    Description

    mild to moderate asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1960046 (Mild persistent asthma)
    SNOMED
    426979002
    UMLS CUI [2]
    C1960047 (Moderate persistent asthma)
    SNOMED
    427295004
    use of budesonide at a dose of 200-800 µg/d (or equivalent corticosteroid therapy) for ≥3 months
    Description

    budesonide

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0054201 (budesonide)
    SNOMED
    108622005
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    stable asthma, defined as no significant change in the regular asthma medication and no acute asthma exacerbation requiring corticosteroid rescue for at least 3 months before enrollment in the run-in phase. asthma symptoms must be under good control
    Description

    stable asthma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [1,2]
    C0205360 (Stable status)
    SNOMED
    58158008
    LOINC
    LP73394-6
    UMLS CUI [2]
    C0349790 (Exacerbation of asthma)
    SNOMED
    281239006
    baseline forced expiratory volume at 1 second (fev-1) >= 70% of the predicted normal value.
    Description

    fev1

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    possible participants treated with orthomolecular therapies within the previous year will require a wash out period of 7 days prior to enrolment in the trial. (vitamin c > 200mg, vitamin e >50iu, vitamin b12 > 100µg, magnesium > 200mg, selenium > 50µg, omega-3 > 300mg, quercetin > 3mg, vitamin b6 > 75mg will all be considered orthomolecular doses).
    Description

    orthomolecular therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0029340 (Orthomolecular Therapy)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    known hypersensitivity to any component of the orthomolecular therapy or placebo.
    Description

    hypersensitivity to any component of the orthomolecular therapy or placebo

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0029340 (Orthomolecular Therapy)
    UMLS CUI [1,3]
    C0032042 (Placebos)
    acute infectious sinusitis or respiratory tract infection or active lung disease other than allergic asthma within 1 month or any other significant systemic disease within 3 months of the study entry visit.
    Description

    comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
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    Similar models

    Eligibility Asthma NCT00672529

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00672529
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    male or female aged 7 to 18 years
    boolean
    C0001779 (UMLS CUI [1])
    mild to moderate asthma
    Item
    mild to moderate asthma diagnosed by a respirologist
    boolean
    C1960046 (UMLS CUI [1])
    C1960047 (UMLS CUI [2])
    budesonide
    Item
    use of budesonide at a dose of 200-800 µg/d (or equivalent corticosteroid therapy) for ≥3 months
    boolean
    C0054201 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    stable asthma
    Item
    stable asthma, defined as no significant change in the regular asthma medication and no acute asthma exacerbation requiring corticosteroid rescue for at least 3 months before enrollment in the run-in phase. asthma symptoms must be under good control
    boolean
    C0004096 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0349790 (UMLS CUI [2])
    fev1
    Item
    baseline forced expiratory volume at 1 second (fev-1) >= 70% of the predicted normal value.
    boolean
    C0748133 (UMLS CUI [1])
    orthomolecular therapy
    Item
    possible participants treated with orthomolecular therapies within the previous year will require a wash out period of 7 days prior to enrolment in the trial. (vitamin c > 200mg, vitamin e >50iu, vitamin b12 > 100µg, magnesium > 200mg, selenium > 50µg, omega-3 > 300mg, quercetin > 3mg, vitamin b6 > 75mg will all be considered orthomolecular doses).
    boolean
    C0029340 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    hypersensitivity to any component of the orthomolecular therapy or placebo
    Item
    known hypersensitivity to any component of the orthomolecular therapy or placebo.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0029340 (UMLS CUI [1,2])
    C0032042 (UMLS CUI [1,3])
    comorbidity
    Item
    acute infectious sinusitis or respiratory tract infection or active lung disease other than allergic asthma within 1 month or any other significant systemic disease within 3 months of the study entry visit.
    boolean
    C0009488 (UMLS CUI [1])
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