ID

31578

Beskrivning

Vitamin D and Adipose Tissue Inflammation; ODM derived from: https://clinicaltrials.gov/show/NCT01477034 Sponsor: Fred Hutchinson Cancer Research Center Collaborator: University of Washington Information provided by (Responsible Party): Kratz, Mario, Fred Hutchinson Cancer Research Center

Länk

https://clinicaltrials.gov/show/NCT01477034

Nyckelord

Versioner (2)
  1. 2018-09-06 2018-09-06 -
  2. 2018-09-07 2018-09-07 - Sarah Riepenhausen
Rättsinnehavare

Kratz, Mario, Fred Hutchinson Cancer Research Center

Uppladdad den

7 september 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Vitamin D Deficiency NCT01477034

Engelsk

Eligibility Vitamin D Deficiency NCT01477034

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18-65 years;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
bmi ≥25 kg/m2;
Beskrivning

Bmi

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
plasma 25-oh-vitamin d between 7 and 20 ng/ml
Beskrivning

plasma 25-oh-vitamin d

Datatyp

boolean

Alias
UMLS CUI [1]
C1255280
weight stable to within 10 pounds for 6 months prior to entering the study, and within 30 pounds of their lifetime maximum weight (excluding pregnancy);
Beskrivning

Stability of weight

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0205360
ability to be admitted for ~6.5 hours on three occasions to the fhcrc prevention center,
Beskrivning

Ability to be admitted to the fhcrc prevention center

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C2827364
UMLS CUI [1,3]
C2825164
ability to provide informed written consent;
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
willingness to take vitamin d3 capsules daily for 6 months
Beskrivning

Compliance to protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic disease such as thyroid disease, liver disease, or kidney disease;
Beskrivning

Chronic comorbidity such as thyroid, liver or kidney disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0008679
UMLS CUI [2]
C0341439
UMLS CUI [3]
C1561643
UMLS CUI [4]
C0008679
diabetes mellitus, or fasting glucose >125 mg/dl;
Beskrivning

Diabetes mellitus or fasting glucose > 125 mg/dl

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0428568
chronic inflammatory condition such as autoimmune disease or inflammatory bowel disease;
Beskrivning

Chronic inflammatory condition such as autoimmune disease or inflammatory bowel disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1290886
UMLS CUI [2]
C0004364
UMLS CUI [3]
C1856359
malabsorption syndromes (untreated celiac disease; condition after stomach or intestinal resection);
Beskrivning

malabsorption syndromes such as untreated celiac cisease; condition after stomach or intestinal resection

Datatyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0007570
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0017118
UMLS CUI [4]
C1096244
current or recent (within one month) chronic intake of medications likely to interfere with study endpoints [(insulin, antidiabetics, anabolic steroids, glucocorticosteroids, statins, blood thinners (warfarin, aspirin), non-steroidal anti-inflammatory drugs (if daily)];
Beskrivning

Current or recent drug treatment with likely interference with the study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C4054723
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C4054723
UMLS CUI [2,4]
C1264692
current or recent (within 3 months) intake of vitamin d in excess of 600 iu/day;
Beskrivning

Current or recent intake of vitamin d

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2317047
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C2317047
UMLS CUI [2,2]
C0332185
anemia, recent history (within 3 months) of anemia; recent (within 3 months) blood donation; recent (within 3 months) participation in another study that involved blood draws; or plans to participate in other research that involves blood draws during the study period;
Beskrivning

Current or recent anemia, recent blood donation, recent or planned participation in another study involving blood draws

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0002871
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0002871
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C0178913
pregnancy in the last 6 months, plans to become pregnant during the study period, or current breastfeeding.
Beskrivning

Current, recent or planned pregnancy or breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332185
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
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Similar models

Eligibility Vitamin D Deficiency NCT01477034

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 18-65 years;
boolean
C0001779 (UMLS CUI [1])
Bmi
Item
bmi ≥25 kg/m2;
boolean
C1305855 (UMLS CUI [1])
plasma 25-oh-vitamin d
Item
plasma 25-oh-vitamin d between 7 and 20 ng/ml
boolean
C1255280 (UMLS CUI [1])
Stability of weight
Item
weight stable to within 10 pounds for 6 months prior to entering the study, and within 30 pounds of their lifetime maximum weight (excluding pregnancy);
boolean
C0005910 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Ability to be admitted to the fhcrc prevention center
Item
ability to be admitted for ~6.5 hours on three occasions to the fhcrc prevention center,
boolean
C0085732 (UMLS CUI [1,1])
C2827364 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
Informed consent
Item
ability to provide informed written consent;
boolean
C0021430 (UMLS CUI [1])
Compliance to protocol
Item
willingness to take vitamin d3 capsules daily for 6 months
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic comorbidity such as thyroid, liver or kidney disease
Item
chronic disease such as thyroid disease, liver disease, or kidney disease;
boolean
C0040128 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0341439 (UMLS CUI [2])
C1561643 (UMLS CUI [3])
C0008679 (UMLS CUI [4])
Diabetes mellitus or fasting glucose > 125 mg/dl
Item
diabetes mellitus, or fasting glucose >125 mg/dl;
boolean
C0011849 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
Chronic inflammatory condition such as autoimmune disease or inflammatory bowel disease
Item
chronic inflammatory condition such as autoimmune disease or inflammatory bowel disease;
boolean
C1290886 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C1856359 (UMLS CUI [3])
malabsorption syndromes such as untreated celiac cisease; condition after stomach or intestinal resection
Item
malabsorption syndromes (untreated celiac disease; condition after stomach or intestinal resection);
boolean
C0024523 (UMLS CUI [1])
C0007570 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0017118 (UMLS CUI [3])
C1096244 (UMLS CUI [4])
Current or recent drug treatment with likely interference with the study
Item
current or recent (within one month) chronic intake of medications likely to interfere with study endpoints [(insulin, antidiabetics, anabolic steroids, glucocorticosteroids, statins, blood thinners (warfarin, aspirin), non-steroidal anti-inflammatory drugs (if daily)];
boolean
C0013216 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C4054723 (UMLS CUI [2,3])
C1264692 (UMLS CUI [2,4])
Current or recent intake of vitamin d
Item
current or recent (within 3 months) intake of vitamin d in excess of 600 iu/day;
boolean
C2317047 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C2317047 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Current or recent anemia, recent blood donation, recent or planned participation in another study involving blood draws
Item
anemia, recent history (within 3 months) of anemia; recent (within 3 months) blood donation; recent (within 3 months) participation in another study that involved blood draws; or plans to participate in other research that involves blood draws during the study period;
boolean
C0332185 (UMLS CUI [1,1])
C0002871 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0002871 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4,1])
C0178913 (UMLS CUI [4,2])
Current, recent or planned pregnancy or breastfeeding
Item
pregnancy in the last 6 months, plans to become pregnant during the study period, or current breastfeeding.
boolean
C0032961 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0032992 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
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