Actively Recruiting
Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of Chronic Proton Pump Inhibitor Therapy
Led by University of Texas Southwestern Medical Center · Updated on 2025-05-23
56
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of effervescent calcium magnesium citrate (EffCaMgCit) to prevent complications associated with long-term use of proton pump inhibitors (PPIs). PPIs are commonly used to treat gastric ulcers, gastroesophageal reflux disease, peptic ulcers, and heartburn, but their use has been linked to risks such as osteoporosis, magnesium deficiency, and chronic kidney disease (CKD). This trial aims to determine whether EffCaMgCit can reduce these complications in adults taking chronic PPI therapy. The trial is a randomized, quadruple-blind study comparing EffCaMgCit to a placebo. Participants will receive either EffCaMgCit, containing calcium, magnesium, and citrate, or a placebo sachet dissolved in water daily for one year. The study will test if EffCaMgCit stabilizes bone mineral density, improves magnesium levels, and protects kidney function during PPI use. The placebo contains no active mineral components and is taken similarly. Participants will be monitored over one year with assessments at the start and end of the study. Evaluations include bone mineral density scans, measurements of magnesium levels in blood, urine, and muscle, kidney function tests, and hormone levels related to bone health. Researchers will track changes in these measures to assess the impact of EffCaMgCit. Safety and adherence will be observed throughout, with the study concluding after one year of treatment.
CONDITIONS
Brief Title
EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ambulatory adults over 21 years of age of any gender and ethnicity
- Currently taking proton pump inhibitors (omeprazole or equivalent) at 20 mg or more, at least three times per week, for at least 2 months
- Expected to continue PPI use at a similar dose
- Stage 1 hypertension with systolic blood pressure below 140 and diastolic below 90
- 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 7% or higher
- Regular treatment with adrenocorticosteroids, 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive EffCaMgCit or placebo daily to prevent mineral metabolism and renal complications during chronic proton pump inhibitor therapy.
Visits at baseline and 1 year
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
M
Miranda King, MPH
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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