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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05998863
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • EffCaMgCit — DRUG
    Each sachet of EffCaMgCit will contain 19 meq or 380 mg calcium, 10 meq (122 mg) magnesium, and 50 meq total citrate.
  • Placebo — OTHER
    Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate.

Study Details

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).

Key Dates

Start date
Apr 19, 2024
Status verified
May 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change From Baseline in Bone Mineral Density (BMD) T-Score at 1 Year [ Time Frame: Baseline and 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-9107
Miranda King, MPH
[email protected]
214-648-2117
Sudeepa Bhattacharya, MPA
[email protected]
214-648-0394
UT Southwestern Medical CenterDallasTexas75390
Khashayar Sakhaee, MD
[email protected]
214-648-0324
Khashayar Sakhaee, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TXUT Southwestern Medical Center· Dallas, TX

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