The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects
1 other identifier
interventional
17
1 country
1
Brief Summary
The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Apr 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 12, 2006
CompletedFirst Posted
Study publicly available on registry
June 14, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJuly 23, 2007
June 1, 2007
June 12, 2006
July 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
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.
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.
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.
11 days
Interventions
Eligibility Criteria
You may qualify if:
- Healthy ambulatory men and postmenopausal women
- Age 45 to 70
- Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.
You may not qualify if:
- Ionized Ca++ level \<4.39 mg/dl or \>5.02 mg/dl (normal reference range 4.18- 5.02).
- 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
- +45 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
Study Sites (1)
Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (1)
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.
PMID: 18536954DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bess Dawson-Hughes, MD
Human Nutrition Research Center on Aging at Tufts University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 12, 2006
First Posted
June 14, 2006
Study Start
April 1, 2006
Study Completion
March 1, 2007
Last Updated
July 23, 2007
Record last verified: 2007-06