Using EffCaMgCit to prevent complications from long-term PPI use
Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of Chronic Proton Pump Inhibitor Therapy
This study is testing if an effervescent supplement called EffCaMgCit can help prevent bone loss, low magnesium levels, and kidney problems in people who have been using proton pump inhibitors for a long time.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | denosumab |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT05998863 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of effervescent calcium magnesium citrate (EffCaMgCit) in preventing osteoporosis, hypomagnesemia, and chronic kidney disease (CKD) associated with long-term use of proton pump inhibitors (PPIs). Over the course of one year, participants will receive either EffCaMgCit or a placebo, with the primary focus on measuring changes in bone mineral density, magnesium levels, and kidney function. The study aims to provide definitive evidence on whether EffCaMgCit can mitigate these complications in patients taking PPIs.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 who have been taking PPIs regularly for at least two months and have controlled stage 1 hypertension and diabetes.
Not a fit: Patients with end-stage renal failure, uncontrolled diabetes, or those on certain medications that affect mineral metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of osteoporosis, magnesium deficiency, and CKD in patients on long-term PPI therapy.
How similar studies have performed: While the approach of using EffCaMgCit is novel, similar studies have indicated that addressing mineral deficiencies can improve outcomes in patients on long-term PPIs.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dallas, Texas and 1 other locations
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Khashayar Sakhaee, MD — Utsw
- Study coordinator: Khashayar Sakhaee, MD
- Email: Khashayar.Sakhaee@UTSouthwestern.edu
- Phone: 214-648-0324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.