Effect of Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus
18 Years
N/A
Both
Short Segment Barrett's Esophagus, Long Segment Barrett's Esophagus
Trial Information
Effect of Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus
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 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.
Inclusion Criteria:
- Known diagnosis of short-segment or long-segment Barrett's esophagus as previously
made by upper endoscopy showing salmon-colored distal esophageal mucosa and biopsies
revealing intestinal metaplasia with goblet cells. Potential study subjects may be
contacted by mailings or phone calls or may be approached in clinic. Additionally,
potential study subjects may be approached using a web-based recruitment tool.
Informed consent will be obtained by a research coordinator or study investigator.
- Age ≥ 18 years
- Subjects may be taking calcium supplements or have previous history of hypercalcemia
- Subjects may have diabetes mellitus
- Subjects may have a history of prior malignancy except for esophageal adenocarcinoma
- Willing to donate 90 mL of blood and endoscopic mucosal biopsies for research
Exclusion Criteria:
- Pregnancy
- Age < 18 years
- Known chronic liver disease (Child's B cirrhosis)
- Known chronic kidney disease (creatinine ≥ 3.0)
- Esophageal adenocarcinoma
- Allergic reaction to omeprazole
- Allergic reaction to vitamin D
- Unable or unwilling to provide informed consent
- Known hypercalcemia
- Previous ablative therapy for Barrett's esophagus
- Patients on a stable (>/=4 week duration) dose of >2000 IU/day (or equivalent) of
vitamin D supplementation
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Arm 1(no or low grade dysplasia): 15-Prostaglandin dehydrogenase expression
Outcome Description:
To determine whether vitamin D supplementation induces 15-Prostaglandin dehydrogenase expression as measured by RT-PCR in Barrett's esophagus
Outcome Time Frame:
after 12 weeks of vitamin D supplement
Safety Issue:
No
Principal Investigator
Linda Cummings, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CASE12209
NCT ID:
NCT01465113
Start Date:
May 2010
Completion Date:
Related Keywords:
- Short Segment Barrett's Esophagus
- Long Segment Barrett's Esophagus
- Barrett's Esophagus
- Vitamin D3
- cholecalciferol
- 15-Prostaglandin Dehydrogenase Expression
- Barrett Esophagus
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
| University Hospitals Ahuja Medical Center | Beachwood, Ohio 44122 |
