EffCaMgCit for Low Magnesium and Osteoporosis Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial requires that you continue taking your proton pump inhibitor (PPI) at a similar dosage. However, if you are taking certain other medications like adrenocorticosteroids, diuretics, or regular magnesium supplements, you may need to stop. Other medications will be considered individually.
Is EffCaMgCit safe for human use?
How does the treatment EffCaMgCit differ from other osteoporosis treatments?
EffCaMgCit is unique because it combines calcium and magnesium in an effervescent form, which may enhance absorption compared to other calcium supplements. This combination could potentially improve bone health by addressing both calcium and magnesium deficiencies, which are important for bone metabolism.16789
What data supports the effectiveness of the treatment EffCaMgCit for preventing osteoporosis?
Research suggests that magnesium supplementation can promote bone formation and prevent bone loss, which may help in osteoporosis prevention. Additionally, higher calcium intake is associated with a reduced risk of osteoporotic fractures, especially when the calcium to magnesium intake ratio is balanced.1581011
Who Is on the Research Team?
Khashayar Sakhaee, MD
Principal Investigator
UTSW
Are You a Good Fit for This Trial?
This trial is for adults over 21 who have been using proton pump inhibitors (like omeprazole) regularly and are expected to continue. They should have stage 1 hypertension, controlled type II diabetes with HbA1C under 7%, and no severe kidney issues or other conditions that require certain medications like steroids or bisphosphonates.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EffCaMgCit or placebo for 1 year to assess prevention of osteoporosis, hypomagnesemia, and CKD
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Effervescent Calcium Magnesium Citrate
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor