ID

28930

Description

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00552409

Link

https://clinicaltrials.gov/show/NCT00552409

Keywords

Versions (1)
  1. 2/17/18 2/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00552409

English

Eligibility Diabetes Mellitus NCT00552409

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
urine albumin-creatinine ratio 30-1000 mg/g
Description

Urine albumin/creatinine ratio measurement

Data type

boolean

Alias
UMLS CUI [1]
C0455271
estimated glomerular filtration rate greater than or equal to 60 ml/min
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
treatment with angiotensin converting enzyme inhibitor and/or angiotensin ii receptor blocker for greater than or equal to 6 months, with a stable dose for greater than or equal to 3 months
Description

Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
UMLS CUI [3,1]
C0003015
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0521942
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
blood pressure less than 140/90 (assessed while taking medications)
Description

Blood pressure determination | Intake Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0013227
hemoglobin a1c less than 9% (assessed while taking medications)
Description

Glucohemoglobin measurement | Intake Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0013227
25-hydroxyvitamin d less than 30 ng/ml
Description

25-Hydroxyvitamin D Measurement

Data type

boolean

Alias
UMLS CUI [1]
C2984945
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior dialysis or kidney transplantation
Description

Dialysis | Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0022671
known cause of albuminuria other than diabetes
Description

Cause Albuminuria | Exception Diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0001925
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011847
planning to leave the area within 12 months
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
life expectancy less than 12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
participation in another clinical trial within 6 months
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
osteoporosis or other established indication for vitamin d therapy
Description

Osteoporosis | Indication Established Vitamin D supplement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0029456
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0443211
UMLS CUI [2,3]
C0420176
vitamin d3 supplement intake greater than 400 iu/day at screening visit
Description

Vitamin D3 Supplement U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C3265062
UMLS CUI [1,2]
C2348609
UMLS CUI [1,3]
C0456683
history of nephrolithiasis
Description

Nephrolithiasis

Data type

boolean

Alias
UMLS CUI [1]
C0392525
serum calcium greater than 10.2 mg/dl
Description

Serum calcium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0728876
dementia, not fluent in english, or unable to provide informed consent without proxy respondent
Description

Dementia | Lacking Able to speak fluently English Language | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0564241
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
incontinent of urine
Description

Urinary Incontinence

Data type

boolean

Alias
UMLS CUI [1]
C0042024
failure to take greater than or equal to 80% of placebo pills during study run-in
Description

Intake Placebo Pills Percentage failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C1696465
UMLS CUI [1,3]
C0994475
UMLS CUI [1,4]
C0439165
UMLS CUI [1,5]
C0231175
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Similar models

Eligibility Diabetes Mellitus NCT00552409

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Urine albumin/creatinine ratio measurement
Item
urine albumin-creatinine ratio 30-1000 mg/g
boolean
C0455271 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate greater than or equal to 60 ml/min
boolean
C3811844 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable
Item
treatment with angiotensin converting enzyme inhibitor and/or angiotensin ii receptor blocker for greater than or equal to 6 months, with a stable dose for greater than or equal to 3 months
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
C0003015 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0521942 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Blood pressure determination | Intake Pharmaceutical Preparations
Item
blood pressure less than 140/90 (assessed while taking medications)
boolean
C0005824 (UMLS CUI [1])
C1512806 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Glucohemoglobin measurement | Intake Pharmaceutical Preparations
Item
hemoglobin a1c less than 9% (assessed while taking medications)
boolean
C0202054 (UMLS CUI [1])
C1512806 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
25-Hydroxyvitamin D Measurement
Item
25-hydroxyvitamin d less than 30 ng/ml
boolean
C2984945 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Dialysis | Kidney Transplantation
Item
prior dialysis or kidney transplantation
boolean
C0011946 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
Cause Albuminuria | Exception Diabetes
Item
known cause of albuminuria other than diabetes
boolean
C0015127 (UMLS CUI [1,1])
C0001925 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011847 (UMLS CUI [2,2])
Relocation of home Planned
Item
planning to leave the area within 12 months
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy less than 12 months
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in another clinical trial within 6 months
boolean
C2348568 (UMLS CUI [1])
Osteoporosis | Indication Established Vitamin D supplement therapy
Item
osteoporosis or other established indication for vitamin d therapy
boolean
C0029456 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0443211 (UMLS CUI [2,2])
C0420176 (UMLS CUI [2,3])
Vitamin D3 Supplement U/day
Item
vitamin d3 supplement intake greater than 400 iu/day at screening visit
boolean
C3265062 (UMLS CUI [1,1])
C2348609 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Nephrolithiasis
Item
history of nephrolithiasis
boolean
C0392525 (UMLS CUI [1])
Serum calcium measurement
Item
serum calcium greater than 10.2 mg/dl
boolean
C0728876 (UMLS CUI [1])
Dementia | Lacking Able to speak fluently English Language | Informed Consent Unable
Item
dementia, not fluent in english, or unable to provide informed consent without proxy respondent
boolean
C0497327 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C0564241 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Urinary Incontinence
Item
incontinent of urine
boolean
C0042024 (UMLS CUI [1])
Intake Placebo Pills Percentage failed
Item
failure to take greater than or equal to 80% of placebo pills during study run-in
boolean
C1512806 (UMLS CUI [1,1])
C1696465 (UMLS CUI [1,2])
C0994475 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0231175 (UMLS CUI [1,5])
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