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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 99
Healthy Volunteers: t
View:

• 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%

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Khashayar Sakhaee, MD
Khashayar.Sakhaee@UTSouthwestern.edu
214-648-0324
Backup
Miranda King, MPH
Miranda.King@utsouthwestern.edu
214-648-2117
Time Frame
Start Date: 2024-04-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 56
Treatments
Experimental: EffCaMgCit
38 meq (760 mg) Ca, 20 meq (243 mg) Mg, and 100 meq total citrate per day; designed to be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing.
Placebo_comparator: Placebo
Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate. Placebo will be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing.
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov