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The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00336739
First received: June 12, 2006
Last updated: July 20, 2007
Last verified: June 2007
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Drug: cinacalcet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided by Tufts University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Tufts University:
Gastric acidity determination
Calcium sensing receptor

ClinicalTrials.gov processed this record on June 17, 2013