ID

27976

Description

Vitamin D Repletion in Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00772772

Link

https://clinicaltrials.gov/show/NCT00772772

Keywords

Versions (1)
  1. 12/7/17 12/7/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00772772

English

Eligibility Chronic Kidney Disease NCT00772772

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria for healthy volunteers
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
males and post-menopausal females, between the age of 50 -80.
Description

Gender | Postmenopausal state | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
vitamin d 25-oh level less than 20 ng/ml
Description

Low 25-OH-vitamin D level

Data type

boolean

Alias
UMLS CUI [1]
C3279609
inclusion criteria for medium-level kidney function volunteers
Description

Volunteers | Renal function Level Medium

Data type

boolean

Alias
UMLS CUI [1]
C0020155
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C0439536
males and post-menopausal females, between the age of 50 -80.
Description

Gender | Postmenopausal state | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
chronic kidney disease stage 3
Description

Chronic Kidney Disease Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
vitamin d 25-oh level less than 20 ng/ml
Description

Low 25-OH-vitamin D level

Data type

boolean

Alias
UMLS CUI [1]
C3279609
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serum calcium level >10.5 mg/dl
Description

Serum calcium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0728876
serum phosphorus level > 5.5 mg/dl
Description

Serum phosphorus measurement

Data type

boolean

Alias
UMLS CUI [1]
C2229833
serum pth level < 35 pg/ml
Description

Serum parathyroid hormone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428408
active infection including hiv, hepatitis b or c
Description

Communicable Disease | HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
history of recent acute infection ( within 1 month)
Description

Recent infection

Data type

boolean

Alias
UMLS CUI [1]
C2169571
gastrointestinal disease resulting in significant gi dysfunction or malabsorption
Description

Gastrointestinal Disease Resulting in Gastrointestinal dysfunction | Gastrointestinal Disease Resulting in Malabsorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0679407
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C3714745
hgb< 10 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
current use of coumadin
Description

Coumadin

Data type

boolean

Alias
UMLS CUI [1]
C0699129
current use of vitamin d >400 iu/day
Description

Vitamin D IU/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0042866
UMLS CUI [1,2]
C0439465
current use of systemic steroids or other immunosuppressants
Description

Systemic steroids | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C0021081
history of malignancy not in remission (>6 months)
Description

Malignant Neoplasms | Remission Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0544452
UMLS CUI [2,2]
C0332268
history of current ethanol abuse or illicit drug use
Description

Alcohol abuse | Illicit drug use

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0281875
history of significant emotional disorder within the past 5 years
Description

Emotional disorder

Data type

boolean

Alias
UMLS CUI [1]
C0233459
participation in an investigational drug study within one month of screening
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
Description

Condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
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Similar models

Eligibility Chronic Kidney Disease NCT00772772

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers
Item
inclusion criteria for healthy volunteers
boolean
C1708335 (UMLS CUI [1])
Gender | Postmenopausal state | Age
Item
males and post-menopausal females, between the age of 50 -80.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Low 25-OH-vitamin D level
Item
vitamin d 25-oh level less than 20 ng/ml
boolean
C3279609 (UMLS CUI [1])
Volunteers | Renal function Level Medium
Item
inclusion criteria for medium-level kidney function volunteers
boolean
C0020155 (UMLS CUI [1])
C0232804 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0439536 (UMLS CUI [2,3])
Gender | Postmenopausal state | Age
Item
males and post-menopausal females, between the age of 50 -80.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Chronic Kidney Disease Stage
Item
chronic kidney disease stage 3
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
Low 25-OH-vitamin D level
Item
vitamin d 25-oh level less than 20 ng/ml
boolean
C3279609 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Serum calcium measurement
Item
serum calcium level >10.5 mg/dl
boolean
C0728876 (UMLS CUI [1])
Serum phosphorus measurement
Item
serum phosphorus level > 5.5 mg/dl
boolean
C2229833 (UMLS CUI [1])
Serum parathyroid hormone measurement
Item
serum pth level < 35 pg/ml
boolean
C0428408 (UMLS CUI [1])
Communicable Disease | HIV Infection | Hepatitis B | Hepatitis C
Item
active infection including hiv, hepatitis b or c
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Recent infection
Item
history of recent acute infection ( within 1 month)
boolean
C2169571 (UMLS CUI [1])
Gastrointestinal Disease Resulting in Gastrointestinal dysfunction | Gastrointestinal Disease Resulting in Malabsorption
Item
gastrointestinal disease resulting in significant gi dysfunction or malabsorption
boolean
C0017178 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0679407 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C3714745 (UMLS CUI [2,3])
Hemoglobin measurement
Item
hgb< 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Coumadin
Item
current use of coumadin
boolean
C0699129 (UMLS CUI [1])
Vitamin D IU/day
Item
current use of vitamin d >400 iu/day
boolean
C0042866 (UMLS CUI [1,1])
C0439465 (UMLS CUI [1,2])
Systemic steroids | Immunosuppressive Agents
Item
current use of systemic steroids or other immunosuppressants
boolean
C2825233 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Malignant Neoplasms | Remission Lacking
Item
history of malignancy not in remission (>6 months)
boolean
C0006826 (UMLS CUI [1])
C0544452 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Alcohol abuse | Illicit drug use
Item
history of current ethanol abuse or illicit drug use
boolean
C0085762 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
Emotional disorder
Item
history of significant emotional disorder within the past 5 years
boolean
C0233459 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in an investigational drug study within one month of screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Condition Study Subject Participation Status Excluded
Item
have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
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