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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Magnesium citrate

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.