HealthyNCT00336739
The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects
A study testing cinacalcet in people with Healthy, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cinacalcet
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy ambulatory men and postmenopausal women
- Age 45 to 70
- Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.
Who cannot join
- 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.
Show all 60Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.
Read the 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
- Being tested
- cinacalcet
- Keywords
- Gastric acidity determination, Calcium sensing receptor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinacalcetDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 days
Secondary outcomes (4)
Compare serum gastrin levels in subjects before and after an 11-day course of cinacalcet or placebo and on a fixed protein metabolic diet.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startApr 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Investigators
- Bess Dawson-Hughes, MD, Principal investigator, Human Nutrition Research Center on Aging at Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336739
- Sponsor's protocol ID
- 2455
- Status last verified
- Jun 2007
- First submitted
- 12 Jun 2006
- Last updated
- 23 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18536954
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00336739
- Acronym / sponsor ID
- 2455
- Conditions
- Healthy
- Keywords
- Gastric acidity determination, Calcium sensing receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 14 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy ambulatory men and postmenopausal women
- Age 45 to 70
- Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.
Key exclusion criteria (60 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cinacalcet | Drug | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2007.
- Derived from this study: PubMed 18536954Ceglia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bess Dawson-Hughes, MD principal investigator
Human Nutrition Research Center on Aging at Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cinacalcet in people with Healthy, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 60 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00336739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2007.