ID

38166

Description

High Dose Vitamin D vs Standard Dose Vitamin D Study; ODM derived from: https://clinicaltrials.gov/show/NCT01988090

Link

https://clinicaltrials.gov/show/NCT01988090

Keywords

Versions (1)
  1. 9/23/19 9/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01988090

English

Eligibility Breast Cancer NCT01988090

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all participants must be female and at least 21 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must have had histologically confirmed stage i-iii breast carcinoma that is positive for estrogen receptor (er) and/or progesterone receptor (pr).
Description

Oestrogen receptor positive breast cancer TNM Breast tumor staging | Breast Carcinoma Progesterone receptor positive TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C2938924
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C0474926
post-menopausal
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6 weeks
Description

Aromatase Inhibitors Adjuvant therapy Beginning

Data type

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0677850
UMLS CUI [1,3]
C0439659
bisphosphonates are allowed at the treating investigator¡¦s discretion
Description

Diphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0012544
performance status (who/ecog scale) 0-2.
Description

WHO performance status scale | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of kidney stones
Description

Kidney Calculi

Data type

boolean

Alias
UMLS CUI [1]
C0022650
hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory's normal parameters
Description

Hypercalcemia

Data type

boolean

Alias
UMLS CUI [1]
C0020437
history of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator's discretion
Description

Hypercalcemia Symptomatic | Hyperparathyroidism Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0020502
UMLS CUI [2,2]
C0231220
baseline vitamin d level greater than 50 ng/ml
Description

Vitamin D measurement

Data type

boolean

Alias
UMLS CUI [1]
C0919758
inability or unwillingness to comply with, or follow study procedures.
Description

Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
currently taking phenytoin or phenobarbital -7 currently taking cholestyramine or orlistat
Description

Phenytoin | Phenobarbital | Cholestyramine | orlistat

Data type

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0031412
UMLS CUI [3]
C0008402
UMLS CUI [4]
C0076275
malabsorption syndrome, such as crohn's disease
Description

Malabsorption Syndrome | Crohn Disease

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0010346
prohibited therapies: patients may not take additional calcium and vitamin d aside from the study medications. patients who are on cholestyramine or orlistat will not be allowed on the trial. also, patients who are taking phenytoin or phenobarbital are not allowed on the trial either because of interaction between vitamin d and anti-epileptic medications.
Description

Therapies Illicit | Calcium Additional | Vitamin D Additional | Cholestyramine | orlistat | Phenytoin | Phenobarbital

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
UMLS CUI [2,1]
C0006675
UMLS CUI [2,2]
C1524062
UMLS CUI [3,1]
C0042866
UMLS CUI [3,2]
C1524062
UMLS CUI [4]
C0008402
UMLS CUI [5]
C0076275
UMLS CUI [6]
C0031507
UMLS CUI [7]
C0031412
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Similar models

Eligibility Breast Cancer NCT01988090

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
all participants must be female and at least 21 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Oestrogen receptor positive breast cancer TNM Breast tumor staging | Breast Carcinoma Progesterone receptor positive TNM Breast tumor staging
Item
patients must have had histologically confirmed stage i-iii breast carcinoma that is positive for estrogen receptor (er) and/or progesterone receptor (pr).
boolean
C2938924 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
Postmenopausal state
Item
post-menopausal
boolean
C0232970 (UMLS CUI [1])
Aromatase Inhibitors Adjuvant therapy Beginning
Item
beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6 weeks
boolean
C0593802 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Diphosphonates
Item
bisphosphonates are allowed at the treating investigator¡¦s discretion
boolean
C0012544 (UMLS CUI [1])
WHO performance status scale | ECOG performance status
Item
performance status (who/ecog scale) 0-2.
boolean
C1298650 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Kidney Calculi
Item
history of kidney stones
boolean
C0022650 (UMLS CUI [1])
Hypercalcemia
Item
hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory's normal parameters
boolean
C0020437 (UMLS CUI [1])
Hypercalcemia Symptomatic | Hyperparathyroidism Symptomatic
Item
history of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator's discretion
boolean
C0020437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0020502 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Vitamin D measurement
Item
baseline vitamin d level greater than 50 ng/ml
boolean
C0919758 (UMLS CUI [1])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
inability or unwillingness to comply with, or follow study procedures.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Phenytoin | Phenobarbital | Cholestyramine | orlistat
Item
currently taking phenytoin or phenobarbital -7 currently taking cholestyramine or orlistat
boolean
C0031507 (UMLS CUI [1])
C0031412 (UMLS CUI [2])
C0008402 (UMLS CUI [3])
C0076275 (UMLS CUI [4])
Malabsorption Syndrome | Crohn Disease
Item
malabsorption syndrome, such as crohn's disease
boolean
C0024523 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
Therapies Illicit | Calcium Additional | Vitamin D Additional | Cholestyramine | orlistat | Phenytoin | Phenobarbital
Item
prohibited therapies: patients may not take additional calcium and vitamin d aside from the study medications. patients who are on cholestyramine or orlistat will not be allowed on the trial. also, patients who are taking phenytoin or phenobarbital are not allowed on the trial either because of interaction between vitamin d and anti-epileptic medications.
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0006675 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0042866 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0008402 (UMLS CUI [4])
C0076275 (UMLS CUI [5])
C0031507 (UMLS CUI [6])
C0031412 (UMLS CUI [7])
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