Status:
TERMINATED
Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate
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 a single-dose bioavailability study, the investigators showed previously that provision of calcium and magnesium in a soluble form as EffCaMgCit improved intestinal absorption of calcium and magnes...
Eligibility Criteria
Inclusion
- 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.
- Inclusion/exclusion of other drugs or conditions will be considered on an individual basis.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03812380
Start Date
January 1 2019
End Date
August 11 2021
Last Update
August 17 2022
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390