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NCT03812380 · ClinicalTrials.gov registry record · Phase 3
Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate
A Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT03812380: Clinical Trial Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
NCT03812380 is a Phase 3 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03812380, a Phase 3 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study 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).
Primary Outcome
Change from baseline in bone mineral density (BMD) T-Score at 2 years as measured by dual photon absorptiometry. The range, as defined by the World Health Organization (WHO), for T-Score is: -1 and above = Normal, Between -1 and -2.5 = Osteopenia, -2.5 and below = osteoporosis.
Interventions
- OTHER Placebo
- DRUG EffCaMgCit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2021-08-11 |
| Phase | Phase 3 |
Why NCT03812380 stopped before completion
NCT03812380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03812380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03812380 about?
NCT03812380 is a clinical study titled "Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate". 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 (osteop...
What is the current status of trial NCT03812380?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2019-01-01. Estimated completion is 2021-08-11.
What interventions are being tested in trial NCT03812380?
The interventions under investigation include: Placebo (OTHER), EffCaMgCit (DRUG).
Who is sponsoring clinical trial NCT03812380?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03812380's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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