EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy

Description

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

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Study Overview

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Study Details

Study overview

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).

Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of Chronic Proton Pump Inhibitor Therapy

EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy

Condition
Osteoporosis
Intervention / Treatment

-

Contacts and Locations

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390-9107

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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%
  • * 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

Ages Eligible for Study

21 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Khashayar Sakhaee, MD, PRINCIPAL_INVESTIGATOR, UTSW

Study Record Dates

2025-12-31