drugset / Trial / NCT03812380

Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate

NCT03812380 ↗

Phase 3 Terminated 62 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupQuadruple-blindPrevention

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).

Timeline

Start
2019-01-01
Primary completion
2021-08-11
Completion
2021-08-11

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated due to a severe decrease in enrollment over the years 2020 and 2021. The major obstacle which hindered participation of subjects was the COVID-19 pandemic. Research was halted. Remaining study patients were withdrawn.”

Drugs

EvaluationDrugModalityDoseRoute
Subject EffCaMgCit Unknown 50 meq —
Subject EffCaMgCit Unknown 122 mg —
Subject EffCaMgCit Unknown 380 mg —
Subject EffCaMgCit Unknown 400 iu —