ID

36942

Description

High-dose Vitamin D Supplementation for ADT-induced Side Effects; ODM derived from: https://clinicaltrials.gov/show/NCT02064946

Link

https://clinicaltrials.gov/show/NCT02064946

Keywords

Versions (1)
  1. 6/22/19 6/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02064946

English

Eligibility Prostatic Neoplasms NCT02064946

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a confirmed diagnosis of stage i-iiia prostate cancer
Description

Prostate carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3258246
within 6 months of starting adt with an additional 6 more months planned.
Description

Antiandrogen therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279492
participants must have sub-optimal vitamin d levels of <32 ng/ml.
Description

Serum vitamin D measurement Suboptimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0428586
UMLS CUI [1,2]
C2984009
participants must agree not to take calcium and/or vitamin d supplements for the duration of the intervention other than those provided.
Description

CALCIUM SUPPLEMENTS Absent | Vitamin D supplement Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3540037
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3541352
UMLS CUI [2,2]
C0332197
participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/l) and a total corrected serum calcium of ≤10.5 mg/dl.
Description

Measurement of serum ionized calcium | Corrected serum calcium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201927
UMLS CUI [2]
C0455288
no contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician.
Description

Medical contraindication Absent Fitness Testing | Physical impairment Absent | Cardiorespiratory problems Absent | Orthopedic problem Absent | Neurologic Deficits Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C4279962
UMLS CUI [2,1]
C0231171
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0260707
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0029354
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0521654
UMLS CUI [5,2]
C0332197
able to read english (since the assessment materials are in printed format).
Description

Able to read English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
able to swallow medication and provide written informed consent.
Description

Able to swallow Oral medication | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2]
C0021430
60 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously verified diagnosis of osteoporosis (any t-score ≤ -2.5).
Description

Osteoporosis T score

Data type

boolean

Alias
UMLS CUI [1,1]
C0029456
UMLS CUI [1,2]
C3854607
patients on antiresorptive drugs (i.e. bisphosphonates) within the past year.
Description

Antiresorptive Agents | Diphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0521941
UMLS CUI [2]
C0012544
patients with hypercalcemia (corrected serum ca > 10.5 mg/dl) or a history of hypercalcemia or vitamin d toxicity/sensitivity.
Description

Hypercalcemia | Corrected serum calcium measurement | Poisoning by vitamin D | Vitamin D allergy

Data type

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2]
C0455288
UMLS CUI [3]
C0242154
UMLS CUI [4]
C0571828
patients with impaired renal function (crcl < 60 ml/min) or who had kidney stones (calcium salt) within the past 5 years.
Description

Renal Insufficiency | Creatinine clearance measurement | Kidney Calculi

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0022650
myocardial infarction within the past year.
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
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Similar models

Eligibility Prostatic Neoplasms NCT02064946

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma TNM clinical staging
Item
have a confirmed diagnosis of stage i-iiia prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Antiandrogen therapy
Item
within 6 months of starting adt with an additional 6 more months planned.
boolean
C0279492 (UMLS CUI [1])
Serum vitamin D measurement Suboptimal
Item
participants must have sub-optimal vitamin d levels of <32 ng/ml.
boolean
C0428586 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
CALCIUM SUPPLEMENTS Absent | Vitamin D supplement Absent
Item
participants must agree not to take calcium and/or vitamin d supplements for the duration of the intervention other than those provided.
boolean
C3540037 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3541352 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurement of serum ionized calcium | Corrected serum calcium measurement
Item
participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/l) and a total corrected serum calcium of ≤10.5 mg/dl.
boolean
C0201927 (UMLS CUI [1])
C0455288 (UMLS CUI [2])
Medical contraindication Absent Fitness Testing | Physical impairment Absent | Cardiorespiratory problems Absent | Orthopedic problem Absent | Neurologic Deficits Absent
Item
no contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician.
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4279962 (UMLS CUI [1,3])
C0231171 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0260707 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0029354 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0521654 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Able to read English Language
Item
able to read english (since the assessment materials are in printed format).
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Able to swallow Oral medication | Informed Consent
Item
able to swallow medication and provide written informed consent.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Age
Item
60 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Osteoporosis T score
Item
previously verified diagnosis of osteoporosis (any t-score ≤ -2.5).
boolean
C0029456 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Antiresorptive Agents | Diphosphonates
Item
patients on antiresorptive drugs (i.e. bisphosphonates) within the past year.
boolean
C0521941 (UMLS CUI [1])
C0012544 (UMLS CUI [2])
Hypercalcemia | Corrected serum calcium measurement | Poisoning by vitamin D | Vitamin D allergy
Item
patients with hypercalcemia (corrected serum ca > 10.5 mg/dl) or a history of hypercalcemia or vitamin d toxicity/sensitivity.
boolean
C0020437 (UMLS CUI [1])
C0455288 (UMLS CUI [2])
C0242154 (UMLS CUI [3])
C0571828 (UMLS CUI [4])
Renal Insufficiency | Creatinine clearance measurement | Kidney Calculi
Item
patients with impaired renal function (crcl < 60 ml/min) or who had kidney stones (calcium salt) within the past 5 years.
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0022650 (UMLS CUI [3])
Myocardial Infarction
Item
myocardial infarction within the past year.
boolean
C0027051 (UMLS CUI [1])
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