DNA Changes That Affect Vitamin D Metabolism in Patients With Colorectal Cancer Receiving Vitamin D Supplements
NCT ID: NCT00550563
Last Updated: 2017-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2007-08-31
2010-07-31
Brief Summary
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PURPOSE: This clinical trial is studying changes in DNA that affect vitamin D metabolism in patients with colorectal cancer receiving vitamin D supplements.
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Detailed Description
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* To identify CYP24 single nucleotide polymorphisms (SNPs) using peripheral blood mononuclear cell genomic DNA from patients with colorectal cancer receiving cholecalciferol supplementation.
* To evaluate the effects of these CYP24 SNPs on baseline serum vitamin D\_3 metabolites (25-D\_3, 24,25-D\_3, and 1,25-D\_3), and parathyroid hormone levels (PTH).
* To evaluate the effects of these CYP24 SNPs on serum vitamin D\_3 metabolites and PTH levels during cholecalciferol treatment.
* To examine CYP24 splicing, protein expression, and enzyme activity at baseline and during cholecalciferol treatment.
* To determine the relationship, if any, between serum cholecalciferol pharmacokinetic parameters and CYP24 SNPs, splicing variants, and enzyme activity.
OUTLINE: Patients receive oral cholecalciferol 2000 IU once daily for 1 year. Patients without response to vitamin D supplementation (serum 25-D\_3 level \< 32 ng/mL) by 6 months will have their cholecalciferol dose increased to 4000 IU once daily.
Blood is collected at baseline and on days 14, 30, 60, 90, 180, 270, and 360. Peripheral blood mononuclear cells for CYP24 genotyping, protein expression, enzyme activity, and splicing variants are analyzed by polymerase chain reaction (PCR), western blot, high performance liquid chromatography, and reverse transcriptase PCR, respectively. Serum is analyzed for vitamin D\_3 metabolite levels (by radioimmunoassay), calcium (to monitor for hypercalcemia), and parathyroid hormone assays (to measure vitamin D effect).
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Oral Cholecalciferol
Patients receive oral cholecalciferol 2000 IU once daily for 1 year
cholecalciferol
Oral
polymerase chain reaction
companion study
polymorphism analysis
companion study
protein expression analysis
companion study
reverse transcriptase-polymerase chain reaction
companion study
western blotting
companion study
high performance liquid chromatography
companion study
laboratory biomarker analysis
companion study
pharmacological study
companion study
adjuvant therapy
Additional therapy
immunoscintigraphy
additional testing
Interventions
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cholecalciferol
Oral
polymerase chain reaction
companion study
polymorphism analysis
companion study
protein expression analysis
companion study
reverse transcriptase-polymerase chain reaction
companion study
western blotting
companion study
high performance liquid chromatography
companion study
laboratory biomarker analysis
companion study
pharmacological study
companion study
adjuvant therapy
Additional therapy
immunoscintigraphy
additional testing
Eligibility Criteria
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Inclusion Criteria
* Prior or current documented diagnosis of colorectal cancer
* All stages
* 25OH-D3 level \< 50 ng/mL
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 6 months
* Serum creatinine \< 2.0 mg/dL
* Serum bilirubin \< 2.0 mg/dL
* No prior or current hypercalcemia (defined as albumin corrected serum calcium \< 10.2 mg/dL)
* No known contraindication for vitamin D supplementation
* No genitourinary stones within the past 5 years
* No severe comorbid conditions such as uncompensated heart failure or active infection
PRIOR CONCURRENT THERAPY:
* No supplemental vitamin D beyond what is provided through the study
* At least 2 months since prior vitamin D supplementation exceeding 800 International Units (IU)
* Nondietary vitamin D supplements should not have exceeded 800 IU/day within the past 2 months
18 Years
120 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Marwan Fakih, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-I-99207
Identifier Type: -
Identifier Source: secondary_id
I 99207
Identifier Type: -
Identifier Source: org_study_id
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