EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy (NCT05998863) | Clinical Trial Compass
RecruitingPhase 3
EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy
United States56 participantsStarted 2024-04-19
Plain-language 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. 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).
Who can participate
Age range
21 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Bone Mineral Density (BMD) T-Score at 1 Year
Timeframe: Baseline and 1 year
2
Change From Baseline in the Fractional Excretion of Magnesium (FEMg) at 1 Year
Timeframe: Baseline and 1 year
3
Change from baseline in endogenous creatinine clearance at 1 year.
Timeframe: Baseline and 1 year
4
Change From Baseline in Bone Mineral Density (BMD) Z-Score at 1 Year
Timeframe: Baseline and 1 year
5
Change From Baseline in Free Muscle Magnesium at 1 Year
Timeframe: Baseline and 1 year
Trial details
NCT IDNCT05998863
SponsorUniversity of Texas Southwestern Medical Center