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RECRUITING
NCT05998863
PHASE3

EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

Proton pump inhibitors (PPIs) are widely used for the control of gastric ulcer-gastritis, erosive esophagitis (gastroesophageal reflux disease), peptic ulcer disease (duodenal ulcer), and heartburn. Despite their efficacy, their use has been implicated in possibly causing fragility fractures (osteoporosis), hypomagnesemia (magnesium deficiency) and increased risk of chronic kidney disease (CKD). The current trial represents the investigators ongoing effort to discern whether these complications could be averted by effervescent calcium magnesium citrate (EffCaMgCit).

Official title: Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of Chronic Proton Pump Inhibitor Therapy

Key Details

Gender

All

Age Range

21 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-04-19

Completion Date

2026-12-31

Last Updated

2025-05-23

Healthy Volunteers

Yes

Interventions

DRUG

EffCaMgCit

Each sachet of EffCaMgCit will contain 19 meq or 380 mg calcium, 10 meq (122 mg) magnesium, and 50 meq total citrate.

OTHER

Placebo

Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate.

Locations (2)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States