Status:
COMPLETED
The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects
Lead Sponsor:
Tufts University
Conditions:
Healthy
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.
Detailed Description
The calcium sensing receptor (CaSR) was originally found on parathyroid and renal cells and more recently it has been identified on cells that regulate gastric acid secretion (G cells and parietal cel...
Eligibility Criteria
Inclusion
- Healthy ambulatory men and postmenopausal women
- Age 45 to 70
- Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.
Exclusion
- Ionized Ca++ level \<4.39 mg/dl or \>5.02 mg/dl (normal reference range 4.18- 5.02).
- 24-hour UCa++ excretion \>350 mg.
- Cr \>1.3.
- AST/ALT values \>10% beyond reference range.
- Hgb level \<11.7 g/dl in women and \<13.2 g/dl in men.
- MCV level \>102 UM3.
- Basal acid output \>5 mEq/h in men and \>3.8 mEq/h in women.
- Basal acid output \<1 mEq/h in men and \<0.2 mEq/h in women.
- Age \<45 or \>70.
- Premenopausal or \<1 year post-menopause.
- Individuals following vegan diets.
- Current EtOH abuse.
- Lidocaine allergy. Medications
- Antacids
- H2 blockers
- Proton pump inhibitors
- Carafate
- Anticholinergic agents (i.e. TCA)
- Cholinergic agents
- Antihistamines in the last 3 weeks
- Cogentin
- Adrenergic blockers
- Thiazide diuretics
- Antiplatelet drugs
- Oral and Inhaled Glucocorticoids
- Bisphosphonates
- Raloxifene, Tamoxifen
- Tobacco
- EtOH during study
- rPTH
- Calcitonin
- Ketoconazole/Itraconazole
- Calcitriol
- Paricalcitol
- Drisdol, Ergocalciferol
- Phosphate binders
- Anticoagulant
- Erythromycin
- Hormone replacement therapy except vaginal estrogen creams
- Exclusion Diseases
- Achlorhydria
- Pernicious anemia
- Zollinger Ellison syndrome
- Congestive heart failure
- Esophageal strictures or motility problems
- History of a GI bleed
- Prior upper GI surgery
- Malabsorption
- History of GI malignancy
- GERD, gastritis, duodenitis
- Active peptic ulcer disease
- Gallbladder disease
- Liver disease
- Pancreatitis
- Current kidney stone
- Renal disease
- Current hypoparathyroidism or hyperparathyroidism
- Moderate to Severe coronary artery disease
- Aortic aneurysm
- Seizure disorder
- Current Arrhythmia
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00336739
Start Date
April 1 2006
End Date
March 1 2007
Last Update
July 23 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111