NCT05998863WithdrawnPhase 3
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
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Reason given: No enrollment due to COVID
Brief summary (registry, in English)
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).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 3 Aug 2023
- Start date
- 19 Apr 2024
- Primary completion date
- 25 Jun 2026
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Osteoporosis
- NCT number
- NCT05998863
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- End-stage renal failure on dialysis
- Hypertension stage 2 or higher
Lab values
- Hypophosphatemia (serum P < 2.5 mg/dL)
- 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.
Other
- Hypercalcemia,
Who the study is looking for
- 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%
Age in the registry: 21 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center | Dallas | United States | Unknown status |
| University of Texas Southwestern Medical Center | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.