Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of Chronic Proton Pump Inhibitor Therapy
Osteoporosis, Hypomagnesemia
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Bone mineral density
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.
Sites / Locations
- University of Texas Southwestern Medical Center
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
EffCaMgCit
Placebo
38 meq (760 mg) Ca, 20 meq (243 mg) Mg, and 100 meq total citrate per day; designed to be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing.
Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate. Placebo will be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing.