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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Osteoporosis, Hypomagnesemia

In brief

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).

Key facts

Study ID

NCT05998863

Run by

University of Texas Southwestern Medical Center

People needed

0

Starts

2024-04-19

Expected to finish

2026-06-25

Last updated by the study team

2026-06-30

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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