ID

26236

Beschreibung

Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00427037

Link

https://clinicaltrials.gov/show/NCT00427037

Stichworte

Versionen (1)
  1. 13.10.17 13.10.17 -
Rechteinhaber

see clinicaltrials.gov

Hochgeladen am

13. Oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00427037

Englisch

Eligibility Chronic Kidney Disease NCT00427037

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-85
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ckd stage 3-4 (gfr 15-59 ml/min/1.73 m2 body surface area, calculated by using the mdrd study equation gfr calculator)
Beschreibung

Chronic kidney disease stage 3-4

Datentyp

boolean

Alias
UMLS CUI [1]
C2074731
serum 25(oh)d concentrations ≤ 30 ng/ml, and serum pth levels >70 pg/ml documented within the last six months
Beschreibung

25-oh-vitamin-d3 and parathyroid hormone measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1278060
UMLS CUI [1,2]
C0202159
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of liver failure (serum ast or alt > 3-fold the upper limit of normal)
Beschreibung

Past history of liver failure (ast or alt)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0085605
requiring dialysis at any stage of the study
Beschreibung

Requiring dialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0489652
history of intestinal malabsorption or chronic diarrhea
Beschreibung

undefined item

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0024523
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0401151
serum calcium level (corrected for serum albumin) > 10.5 mg/dl
Beschreibung

Calcium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201925
calcium x phosphorus product >70
Beschreibung

Calcium x phosphorus product

Datentyp

boolean

Alias
UMLS CUI [1]
C0552357
treatment with more than 1000 iu of vitamin d per day, or current treatment with a vitamin d analogue or calcimimetic
Beschreibung

Treatment with concomitant medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0042866
UMLS CUI [1,3]
C3844134
UMLS CUI [2,1]
C2826666
UMLS CUI [2,2]
C0042866
UMLS CUI [3,1]
C2826666
UMLS CUI [3,2]
C1443768
an anti-epileptic medication and other medications which can affect vitamin d metabolism (e.g., phenobarbital, phenytoin, rifampicin)
Beschreibung

Anti-epileptic medication and other medications which can affect vitamin d metabolism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C1159433
UMLS CUI [2,1]
C2826666
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C1159433
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Ähnliche Modelle

Eligibility Chronic Kidney Disease NCT00427037

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-85
boolean
C0001779 (UMLS CUI [1])
Chronic kidney disease stage 3-4
Item
ckd stage 3-4 (gfr 15-59 ml/min/1.73 m2 body surface area, calculated by using the mdrd study equation gfr calculator)
boolean
C2074731 (UMLS CUI [1])
25-oh-vitamin-d3 and parathyroid hormone measurement
Item
serum 25(oh)d concentrations ≤ 30 ng/ml, and serum pth levels >70 pg/ml documented within the last six months
boolean
C1278060 (UMLS CUI [1,1])
C0202159 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Past history of liver failure (ast or alt)
Item
history of liver failure (serum ast or alt > 3-fold the upper limit of normal)
boolean
C0262926 (UMLS CUI [1,1])
C0085605 (UMLS CUI [1,2])
Requiring dialysis
Item
requiring dialysis at any stage of the study
boolean
C0011946 (UMLS CUI [1,1])
C0489652 (UMLS CUI [1,2])
undefined item
Item
history of intestinal malabsorption or chronic diarrhea
boolean
C0262926 (UMLS CUI [1,1])
C0024523 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0401151 (UMLS CUI [2,2])
Calcium measurement
Item
serum calcium level (corrected for serum albumin) > 10.5 mg/dl
boolean
C0201925 (UMLS CUI [1])
Calcium x phosphorus product
Item
calcium x phosphorus product >70
boolean
C0552357 (UMLS CUI [1])
Treatment with concomitant medication
Item
treatment with more than 1000 iu of vitamin d per day, or current treatment with a vitamin d analogue or calcimimetic
boolean
C2826666 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
C3844134 (UMLS CUI [1,3])
C2826666 (UMLS CUI [2,1])
C0042866 (UMLS CUI [2,2])
C2826666 (UMLS CUI [3,1])
C1443768 (UMLS CUI [3,2])
Anti-epileptic medication and other medications which can affect vitamin d metabolism
Item
an anti-epileptic medication and other medications which can affect vitamin d metabolism (e.g., phenobarbital, phenytoin, rifampicin)
boolean
C0003299 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C1159433 (UMLS CUI [1,3])
C2826666 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C1159433 (UMLS CUI [2,3])
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