This study is being conducted to determine if vitamin D supplementation increases the level of a protein that may be involved in decreasing the risk of esophageal cancer in patients with Barrett's esophagus. Subjects with Barrett's esophagus will take vitamin D supplementation for 2-12 weeks depending on the severity of their condition, and receive an upper endoscopy procedure before and after vitamin D supplementation trial.
28-day run-in phase during which subjects are treated with a proton pump inhibitor (omeprazole 20 mg po q day or an equivalent dose of another proton pump inhibitor). The purpose of the run-in phase is to minimize esophagitis, which can cause histologic changes that can be confused with dysplasia. After the run-in phase, subjects will undergo an upper endoscopy for Barrett's surveillance or Barrett's mapping as part of routine clinical care. At the time of endoscopy, research biopsies will be obtained for the study. Subjects eligible and continuing in the study will take vitamin D3 (Cholecalciferol) 50,000 IU capsules once weekly with or without daily metformin for a total of two or twelve weeks depending on the severity of Barrett's esophagus. After completion of vitamin D3 subjects will return for an EGD (endoscopy) and biopsies for the research study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
26
28-day run-in phase during which subjects are treated with a proton pump inhibitor (omeprazole 20 mg po q day or an equivalent dose of another proton pump inhibitor).
These patients (indefinite for dysplasia, LGD, or no dysplasia) will take vitamin D3 50,000 IU once a week for 12 weeks following the upper endoscopy.
Due to the risk of progression, subjects with Barrett's esophagus with high grade dysplasia will take vitamin D3 50,000 IU once a week for 2 weeks.
University Hospitals Ahuja Medical Center
Beachwood, Ohio, United States
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Arm 1(no or low grade dysplasia): 15-Prostaglandin dehydrogenase expression
To determine whether vitamin D supplementation induces 15-Prostaglandin dehydrogenase expression as measured by RT-PCR in Barrett's esophagus
Time frame: after 12 weeks of vitamin D supplement
Arm 2 (high grade dysplasia): 15-Prostaglandin dehydrogenase expression
To determine whether vitamin D supplementation induces 15-Prostaglandin dehydrogenase expression as measured by RT-PCR in Barrett's esophagus
Time frame: after 2 weeks of vitamin D supplement
decreased prostaglandin E2 expression in Barrett's esophagus
To determine whether vitamin D supplementation leads to decreased prostaglandin E2 expression in Barrett's esophagus
Time frame: after 2 or 12 weeks of vitamin D supplement
effects on cyclooxygenase-2 expression
To determine whether vitamin D supplementation affects cyclooxygenase-2 expression in Barrett's esophagus
Time frame: after 2 or 12 weeks after vitamin D supplement
15-Prostaglandin dehydrogenase expression differences between RT-PCR and immunohistochemistry
To determine whether 15-Prostaglandin dehydrogenase expression in Barrett's esophagus differs between RT-PCR and immunohistochemistry
Time frame: after 2 or 12 weeks after vitamin D supplement
effects on levels of Ki-67
To determine whether vitamin D supplementation affects levels of Ki-67, a marker for proliferation, in Barrett's esophagus
Time frame: after 2 or 12 weeks after vitamin D supplement
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After the run-in phase subjects will undergo an upper endoscopy for Barrett's surveillance or Barrett's mapping as part of routine clinical care. At the time of endoscopy, in addition to large cup forceps biopsies obtained for surveillance or mapping as part of standard care, research biopsies will be obtained for the study. Following vitamin D3 supplementation, all subjects will undergo a repeat upper endoscopy for additional large cup forceps biopsies for measurement of post-treatment mucosal levels.
500mg for the first week, 1000mg during the second week, 1500mg during the third week, maximum dose of 2000mg in the fourth week
effects on levels of caspase
To determine whether vitamin D supplementation affects levels of caspase, a marker for apoptosis, in Barrett's esophagus
Time frame: after 2 or 12 weeks of vitamin D supplement
effects on insulin resistance
To determine whether vitamin D supplementation affects insulin resistance in Barrett's esophagus
Time frame: after 2 or 12 weeks of vitamin D supplement