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

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a special product called effervescent calcium magnesium citrate (EffCaMgCit) can help prevent problems that might arise from taking proton pump inhibitors (PPIs), which are medications commonly used for heartburn and stomach issues. Some studies suggest that long-term use of PPIs could lead to bone weakness (osteoporosis), low magnesium levels (hypomagnesemia), and possibly kidney problems. The researchers want to find out if taking EffCaMgCit along with PPIs can reduce these risks.

To be eligible for this trial, participants need to be adults over 21 who have been taking a PPI like omeprazole for at least two months. They should also have mild high blood pressure and controlled Type II diabetes. However, people with severe kidney failure, certain blood conditions, or those taking specific medications may not qualify. If you participate, you will help researchers learn more about how to keep patients safe while using PPIs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ambulatory adult subjects (\> 21 years of age) of either gender of any ethnicity
• • Must have taken PPI (omeprazole or equivalent ≥ 20 mg/day, ≥ three times per week, for at least 2 months)
• • Expected to continue at a similar dosage
• • Stage 1 hypertension (with systolic blood pressure \<140 and diastolic \<90)
• • Controlled diabetes mellitus Type II with HbA1C less than 7%
• Exclusion Criteria:
• • End-stage renal failure on dialysis
• • Hypercalcemia,
• • Hypophosphatemia (serum P \< 2.5 mg/dL)
• • Hypertension stage 2 or higher
• • Diabetes Type II with HbA1C ≥ 7%
• • Treatment with adrenocorticosteroids, diuretics, non-steroidal anti-inflammatory agents - - Regular dose of magnesium supplements, bisphosphonate, teriparatide, denosumab or selective estrogen receptor modulators
• • Required to take calcium
• • Inclusion/exclusion of other drugs or conditions will be considered on an individual basis.