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Completed

NCT Number: NCT00336739

The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects

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

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Key information

Conditions

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cinacalcet

Drug

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.

    Time frame: 11 days

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Jun 14, 2006
Registry last updated
Jul 23, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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