RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-04-19
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05998863

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.

Ages Eligible for Study:21 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ambulatory adult subjects (\> 21 years of age) of either gender of any ethnicity
  2. * Must have taken PPI (omeprazole or equivalent ≥ 20 mg/day, ≥ three times per week, for at least 2 months)
  3. * Expected to continue at a similar dosage
  4. * Stage 1 hypertension (with systolic blood pressure \<140 and diastolic \<90)
  5. * Controlled diabetes mellitus Type II with HbA1C less than 7%
  1. * End-stage renal failure on dialysis
  2. * Hypercalcemia,
  3. * Hypophosphatemia (serum P \< 2.5 mg/dL)
  4. * Hypertension stage 2 or higher
  5. * Diabetes Type II with HbA1C ≥ 7%
  6. * Treatment with adrenocorticosteroids, diuretics, non-steroidal anti-inflammatory agents - - Regular dose of magnesium supplements, bisphosphonate, teriparatide, denosumab or selective estrogen receptor modulators
  7. * Required to take calcium

Contacts and Locations

Study Contact

Khashayar Sakhaee, MD
CONTACT
214-648-0324
Khashayar.Sakhaee@UTSouthwestern.edu
Miranda King, MPH
CONTACT
214-648-2117
Miranda.King@utsouthwestern.edu

Principal Investigator

Khashayar Sakhaee, MD
PRINCIPAL_INVESTIGATOR
UTSW

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Khashayar Sakhaee, MD, PRINCIPAL_INVESTIGATOR, UTSW

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

Study Start Date2024-04-19
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-04-19
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Bone mineral density

Additional Relevant MeSH Terms

  • Osteoporosis
  • Hypomagnesemia