- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00336739
The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects
July 20, 2007 updated by: Tufts University
The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Human Nutrition Research Center on Aging at Tufts University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
11 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
11 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bess Dawson-Hughes, MD, Human Nutrition Research Center on Aging at Tufts University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion
December 7, 2022
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
June 12, 2006
First Submitted That Met QC Criteria
June 12, 2006
First Posted (Estimate)
June 14, 2006
Study Record Updates
Last Update Posted (Estimate)
July 23, 2007
Last Update Submitted That Met QC Criteria
July 20, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2455
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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