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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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% Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

EffCaMgCit

Each sachet of EffCaMgCit will contain 19 meq or 380 mg calcium, 10 meq (122 mg) magnesium, and 50 meq total citrate.

OTHER

Placebo

Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate.

Locations (2)

University of Texas Southwestern Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States