Actively Recruiting
EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy
Led by University of Texas Southwestern Medical Center · Updated on 2025-05-23
56
Participants Needed
2
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 21 years of any gender and ethnicity
- Currently taking proton pump inhibitors (omeprazole or equivalent) at doses of at least 20 mg, three times per week or more, for at least 2 months
- Expected to continue PPI therapy at a similar dosage
- Have stage 1 hypertension with systolic blood pressure below 140 and diastolic below 90
- Have controlled type II diabetes with HbA1C less than 7%
You will not qualify if you...
- End-stage renal failure requiring dialysis
- High blood calcium levels (hypercalcemia)
- Low blood phosphate levels (hypophosphatemia, serum phosphorus below 2.5 mg/dL)
- Hypertension stage 2 or higher
- Type II diabetes with HbA1C of 7% or higher
- Treatment with corticosteroids, diuretics, or non-steroidal anti-inflammatory drugs
- Regular use of magnesium supplements, bisphosphonates, teriparatide, denosumab, or selective estrogen receptor modulators
- Requirement to take calcium supplements
- Other drug or condition exclusions considered individually
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9107
Actively Recruiting
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
K
Khashayar Sakhaee, MD
CONTACT
M
Miranda King, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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