Long Segment Barrett's Esophagus Clinical Trial
Official title:
Effect of Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus
| Verified date | March 2016 |
| Source | Case Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. - 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 The following additional inclusion criteria apply for patients in the Vitamin D/metformin sub-arm of the low grade dysplasia/no dysplasia arm: - At least 2 cm circumferential Barrett's esophagus segment length (C2M2 by Prague C & M criteria) - Normal renal function (defined as creatinine within normal institutional limits) Exclusion Criteria: - Pregnancy - 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 The following additional exclusion criteria apply for patients in the Vitamin D/metformin sub-arm of the no dysplasia/low grade dysplasia arm: - Allergic reaction to metformin - History of diabetes mellitus - History of lactic acidosis - History of B12 deficiency - Participants may not be using metformin, cimetidine (Tagamet) furosemide (Lasix), nifedipine (Cardizem), or any other drug contraindicated for use with metformin. - Treatment with other oral hypoglycemic agents - Participants planning to undergo elective radiologic studies involving intravascular administration of iodinated contrast materials. - Known chronic kidney disease with creatinine greater than normal institutional limits |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Case Comprehensive Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | after 12 weeks of vitamin D supplement | No |
| Primary | 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 | after 2 weeks of vitamin D supplement | No |
| Secondary | decreased prostaglandin E2 expression in Barrett's esophagus | To determine whether vitamin D supplementation leads to decreased prostaglandin E2 expression in Barrett's esophagus | after 2 or 12 weeks of vitamin D supplement | No |
| Secondary | effects on cyclooxygenase-2 expression | To determine whether vitamin D supplementation affects cyclooxygenase-2 expression in Barrett's esophagus | after 2 or 12 weeks after vitamin D supplement | No |
| Secondary | 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 | after 2 or 12 weeks after vitamin D supplement | No |
| Secondary | 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 | after 2 or 12 weeks after vitamin D supplement | No |
| Secondary | effects on levels of caspase | To determine whether vitamin D supplementation affects levels of caspase, a marker for apoptosis, in Barrett's esophagus | after 2 or 12 weeks of vitamin D supplement | No |
| Secondary | effects on insulin resistance | To determine whether vitamin D supplementation affects insulin resistance in Barrett's esophagus | after 2 or 12 weeks of vitamin D supplement | No |