RecruitingPhase 3NCT05998863

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

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

Sponsor

University of Texas Southwestern Medical Center

Enrollment

56 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

Osteoporosis Hypomagnesemia

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).

Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of calcium, magnesium, and citrate supplements can prevent bone, kidney, and mineral problems that can develop in people who take proton pump inhibitors (PPIs — common heartburn and acid reflux medications like omeprazole) for a long time. **You may be eligible if...** - You are over 21 years old - You have been taking a PPI (such as omeprazole, pantoprazole, or similar) at least 3 times per week for at least 2 months, and expect to keep taking it - You have stage 1 high blood pressure (systolic below 140, diastolic below 90) - You have well-controlled type 2 diabetes (HbA1C under 7%) **You may NOT be eligible if...** - You are on dialysis for kidney failure - You have high blood calcium or very low blood phosphate - You have uncontrolled or stage 2 high blood pressure - You are currently taking steroids, diuretics, NSAIDs, bisphosphonates, or regular magnesium supplements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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