The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects

NCT ID: NCT00336739

Last Updated: 2007-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-03-31

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 cells). However, its role in regulating acid secretion in humans is completely unknown and is of potential importance because an acid environment in the stomach enhances intestinal calcium absorption. In this pilot project, we will stimulate the CaSR with a CaSR-agonist called cinacalcet. Our hypothesis is that activation of the CaSR will in turn increase gastric acid production in healthy volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Interventions

cinacalcet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy ambulatory men and postmenopausal women
• Age 45 to 70
• Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Principal Investigators

Bess Dawson-Hughes, MD

Role: PRINCIPAL_INVESTIGATOR

Human Nutrition Research Center on Aging at Tufts University

Locations

Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Countries

United States

References

Ceglia L, Harris SS, Rasmussen HM, Dawson-Hughes B. Activation of the calcium sensing receptor stimulates gastrin and gastric acid secretion in healthy participants. Osteoporos Int. 2009 Jan;20(1):71-8. doi: 10.1007/s00198-008-0637-8. Epub 2008 Jun 7.

Reference Type: DERIVED

PMID: 18536954 (View on PubMed)

Other Identifiers

2455

Identifier Type: -

Identifier Source: org_study_id