ID

14129

Description

Vitamin D and Severe Asthma Exacerbations; ODM derived from: https://clinicaltrials.gov/show/NCT01921894

Link

https://clinicaltrials.gov/show/NCT01921894

Keywords

Versions (1)
  1. 3/30/16 3/30/16 -
Uploaded on

March 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT01921894

English

Eligibility Asthma NCT01921894

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01921894
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
be at least 6 years of age and younger than 15 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have physician-diagnosed asthma
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
taking a medium dose of ics (e.g. fluticasone 220mcg bid) for daily asthma control for at least 6 months in the prior year.
Description

Asthma | inhaled steroids | fluticasone

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2065041
UMLS CUI [3]
C0082607
have had a severe asthma exacerbation in the previous year, defined as an emergency department (ed) visit, hospitalization, or unscheduled clinic visit for asthma resulting in intramuscular, intravenous, or oral steroids.
Description

Exacerbation of severe persistent asthma | Intramuscular steroid therapy | Intravenous steroid injection | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C3508930
UMLS CUI [2]
C0586082
UMLS CUI [3]
C0019993
UMLS CUI [4]
C0585373
UMLS CUI [5]
C0563322
UMLS CUI [6]
C0001617
have bronchodilator responsiveness (bdr, an increase in fev1 ≥12 percent from baseline after administration of inhaled albuterol) or (if no bdr) increased airway responsiveness to methacholine challenge
Description

response to bronchodilator | FEV1 | Inhaled albuterol | Respiratory Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C3548479
UMLS CUI [2]
C0748133
UMLS CUI [3]
C0354688
UMLS CUI [4,1]
C0035228
UMLS CUI [4,2]
C0430567
have vitamin d insufficiency (a serum vitamin d (25(oh)d) level <30 ng/ml)
Description

Vitamin d insufficiency | Serum vitamin D measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0231179
UMLS CUI [1,2]
C0042866
UMLS CUI [2]
C0428586
have his/her parents give voluntary written consent to participate in the study
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic respiratory disorder other than asthma (e.g., bronchiectasis).
Description

Respiration Disorders | Bronchiectasis

Data type

boolean

Alias
UMLS CUI [1]
C0035204
UMLS CUI [2]
C0006267
UMLS CUI [3]
C0004096
severe asthma, as evidenced by any of the following: a) chronic need for medication other than single controller therapy and inhaled β2-agonist, b) intubation for asthma at any time, and c) ≥2 hospitalizations or ≥6 severe asthma exacerbations in the previous year
Description

Severe asthma | medication for chronic disease | Intubation | Hospitalization | Exacerbation of severe persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C3495005
UMLS CUI [3]
C0021925
UMLS CUI [4]
C0019993
UMLS CUI [5]
C3508930
history of cigarette smoking in the prior year or former smoking if ≥5 pack-years
Description

cigarette smoking | pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C2230126
hepatic or renal disease, metabolic rickets, malabsorptive disorders, or other chronic diseases that would affect vitamin d metabolism
Description

Liver diseases | Kidney Diseases | Rickets | Malabsorption | Chronic disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0035579
UMLS CUI [4]
C3714745
UMLS CUI [5,1]
C0008679
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1159433
immune deficiency, cleft palate or down's syndrome, which might increase the child's likelihood of respiratory infections
Description

Immune deficiency | Cleft Palate | Down Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1855771
UMLS CUI [2]
C0008925
UMLS CUI [3]
C0013080
treatment with anticonvulsants or pharmacological doses of vitamin d (≥1,000 iu/day of vitamin d2 or d3)
Description

Therapeutic procedure | Anticonvulsants | Vitamin D

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003286
UMLS CUI [2,1]
C0042866
UMLS CUI [2,2]
C0013058
chronic oral corticosteroid therapy
Description

Therapeutic procedure | Oral steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0001617
inability to perform acceptable spirometry
Description

Unable | Spirometry

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0037981
use of investigational therapies or participation in clinical trials 30 days before or during the duration of the study
Description

Therapies, Investigational | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2]
C2348568
serum calcium >10.8 mg/dl
Description

serum calcium

Data type

boolean

Alias
UMLS CUI [1]
C0728876
serum 25(oh) d <10 ng/ml (severe vitamin d deficiency)
Description

Severe vitamin d deficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0042870
UMLS CUI [1,2]
C0205082
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Similar models

Eligibility Asthma NCT01921894

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01921894
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
be at least 6 years of age and younger than 15 years of age
boolean
C0001779 (UMLS CUI [1])
Asthma
Item
have physician-diagnosed asthma
boolean
C0004096 (UMLS CUI [1])
Asthma | inhaled steroids | fluticasone
Item
taking a medium dose of ics (e.g. fluticasone 220mcg bid) for daily asthma control for at least 6 months in the prior year.
boolean
C0004096 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0082607 (UMLS CUI [3])
Exacerbation of severe persistent asthma | Intramuscular steroid therapy | Intravenous steroid injection | Adrenal Cortex Hormones
Item
have had a severe asthma exacerbation in the previous year, defined as an emergency department (ed) visit, hospitalization, or unscheduled clinic visit for asthma resulting in intramuscular, intravenous, or oral steroids.
boolean
C3508930 (UMLS CUI [1])
C0586082 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
C0585373 (UMLS CUI [4])
C0563322 (UMLS CUI [5])
C0001617 (UMLS CUI [6])
response to bronchodilator | FEV1 | Inhaled albuterol | Respiratory Hypersensitivity
Item
have bronchodilator responsiveness (bdr, an increase in fev1 ≥12 percent from baseline after administration of inhaled albuterol) or (if no bdr) increased airway responsiveness to methacholine challenge
boolean
C3548479 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0354688 (UMLS CUI [3])
C0035228 (UMLS CUI [4,1])
C0430567 (UMLS CUI [4,2])
Vitamin d insufficiency | Serum vitamin D measurement
Item
have vitamin d insufficiency (a serum vitamin d (25(oh)d) level <30 ng/ml)
boolean
C0231179 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
C0428586 (UMLS CUI [2])
Informed consent
Item
have his/her parents give voluntary written consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Respiration Disorders | Bronchiectasis
Item
chronic respiratory disorder other than asthma (e.g., bronchiectasis).
boolean
C0035204 (UMLS CUI [1])
C0006267 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
Severe asthma | medication for chronic disease | Intubation | Hospitalization | Exacerbation of severe persistent asthma
Item
severe asthma, as evidenced by any of the following: a) chronic need for medication other than single controller therapy and inhaled β2-agonist, b) intubation for asthma at any time, and c) ≥2 hospitalizations or ≥6 severe asthma exacerbations in the previous year
boolean
C0581126 (UMLS CUI [1])
C3495005 (UMLS CUI [2])
C0021925 (UMLS CUI [3])
C0019993 (UMLS CUI [4])
C3508930 (UMLS CUI [5])
cigarette smoking | pack-years history
Item
history of cigarette smoking in the prior year or former smoking if ≥5 pack-years
boolean
C0543414 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Liver diseases | Kidney Diseases | Rickets | Malabsorption | Chronic disease
Item
hepatic or renal disease, metabolic rickets, malabsorptive disorders, or other chronic diseases that would affect vitamin d metabolism
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0035579 (UMLS CUI [3])
C3714745 (UMLS CUI [4])
C0008679 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1159433 (UMLS CUI [5,3])
Immune deficiency | Cleft Palate | Down Syndrome
Item
immune deficiency, cleft palate or down's syndrome, which might increase the child's likelihood of respiratory infections
boolean
C1855771 (UMLS CUI [1])
C0008925 (UMLS CUI [2])
C0013080 (UMLS CUI [3])
Therapeutic procedure | Anticonvulsants | Vitamin D
Item
treatment with anticonvulsants or pharmacological doses of vitamin d (≥1,000 iu/day of vitamin d2 or d3)
boolean
C0087111 (UMLS CUI [1,1])
C0003286 (UMLS CUI [1,2])
C0042866 (UMLS CUI [2,1])
C0013058 (UMLS CUI [2,2])
Therapeutic procedure | Oral steroids
Item
chronic oral corticosteroid therapy
boolean
C0087111 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Unable | Spirometry
Item
inability to perform acceptable spirometry
boolean
C1299582 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
Therapies, Investigational | Study Subject Participation Status
Item
use of investigational therapies or participation in clinical trials 30 days before or during the duration of the study
boolean
C0949266 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
serum calcium
Item
serum calcium >10.8 mg/dl
boolean
C0728876 (UMLS CUI [1])
Severe vitamin d deficiency
Item
serum 25(oh) d <10 ng/ml (severe vitamin d deficiency)
boolean
C0042870 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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