The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects - Full Text View

Sponsored by:	Tufts University
Information provided by:	Tufts University
ClinicalTrials.gov Identifier:	NCT00336739

Purpose

The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.

Condition	Intervention
Healthy	Drug: cinacalcet

Drug Information available for: Calcium gluconate Cinacalcet Cinacalcet hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study

Further study details as provided by Tufts University:

Primary Outcome Measures:

Compare change in gastric acid output in response to an 11-day course of daily cinacalcet or placebo in subjects on a fixed protein metabolic diet. [ Time Frame: 11 days ]

Secondary Outcome Measures:

Compare serum gastrin levels in subjects before and after an 11-day course of cinacalcet or placebo and on a fixed protein metabolic diet. [ Time Frame: 11 days ]
Compare 24-hour urinary calcium excretion before and after an 11-day course of cinacalcet or placebo and on a fixed protein metabolic diet. [ Time Frame: 11 days ]
Compare serum IGF-1 levels before and after an 11-day course of cinacalcet or placebo and on a fixed protein metabolic diet. [ Time Frame: 11 days ]
Compare change in urinary magnesium excretion in response to an 11-day course of daily cinacalcet or placebo in subjects on a fixed protein metabolic diet. [ Time Frame: 11 days ]

Enrollment:	17
Study Start Date:	April 2006
Study Completion Date:	March 2007

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.

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336739

Locations

United States, Massachusetts
Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Tufts University

Investigators

Principal Investigator:

Bess Dawson-Hughes, MD

Human Nutrition Research Center on Aging at Tufts University

More Information

Publications indexed to this study:

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. Epub 2008 Jun 7.

Study ID Numbers:	2455
Study First Received:	June 12, 2006
Last Updated:	July 20, 2007
ClinicalTrials.gov Identifier:	NCT00336739
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Tufts University:

Gastric acidity determination
Calcium sensing receptor

Study placed in the following topic categories:

Calcium, Dietary
Healthy

ClinicalTrials.gov processed this record on January 16, 2009