Status:
RECRUITING
EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Osteoporosis
Hypomagnesemia
Eligibility:
All Genders
21-99 years
Phase:
PHASE3
Brief 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. D...
Detailed Description
In the current proposal, the investigators wish to conduct a 1-year treatment trial, directed at obtaining more definitive evidence that EffCaMgCit overcomes all three complications of PPI. Aim 1. To...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05998863
Start Date
April 19 2024
End Date
December 31 2026
Last Update
May 23 2025
Active Locations (2)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9107
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390