EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy
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:
🦠 Osteoporosis 🦠 Hypomagnesemia
🗓️ Study Start (Actual) 19 April 2024
🗓️ Primary Completion (Estimated) 30 September 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 56
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Dallas, Texas, United States
📍 Dallas, Texas, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 21 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 August 2023
  • First Submitted that Met QC Criteria 10 August 2023
  • First Posted 21 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 May 2024
  • Last Update Posted 22 May 2024
  • Last Verified May 2024