56 Participants Needed

EffCaMgCit for Low Magnesium and Osteoporosis Prevention

Recruiting at 1 trial location
KS
MK
Overseen ByMiranda King, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Proton pump inhibitors
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research on similar calcium and magnesium supplements shows they are generally safe for human use, with studies indicating they can be absorbed well and support bone health. However, specific safety data for EffCaMgCit in humans is not directly available from the provided studies.12345

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?

KS

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

I have been taking a strong acid reducer regularly for at least 2 months and will continue.
Your blood pressure is in the range of stage 1 hypertension, which means your systolic (top number) is less than 140 and your diastolic (bottom number) is less than 90.
I am over 21 years old and can walk on my own.
See 1 more

Exclusion Criteria

I am on dialysis for end-stage kidney failure.
Your blood phosphate levels are too low.
My blood pressure is very high.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EffCaMgCit or placebo for 1 year to assess prevention of osteoporosis, hypomagnesemia, and CKD

52 weeks
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Effervescent Calcium Magnesium Citrate
  • Placebo
Trial Overview The study tests if effervescent calcium magnesium citrate can prevent bone weakening, magnesium deficiency, and kidney problems caused by long-term use of proton pump inhibitors. Participants will either receive this supplement (EffCaMgCit) or a placebo without knowing which one they're taking.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EffCaMgCitExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Published Research Related to This Trial

A study comparing calcium absorption in 15 young and 20 elderly women found that soluble calcium citrate and calcium gluconolactate-carbonate are better absorbed than solid calcium citrate, indicating they may be more effective for treating osteoporosis.
Both young and elderly women showed similar absorption patterns, with soluble forms leading to greater increases in plasma calcium and urinary calcium excretion, suggesting that these forms could be beneficial for improving calcium intake in older adults.
Comparative study of the intestinal absorption of three salts of calcium in young and elderly women.Praet, JP., Peretz, A., Mets, T., et al.[2018]
In ovariectomized rats, a higher magnesium diet (0.15%) led to lower calcium absorption but increased bone formation and reduced bone resorption, suggesting a complex role of magnesium in bone health.
Magnesium supplementation improved the dynamic strength of bones, as indicated by higher breaking force and energy in the femurs of rats on the higher magnesium diet, highlighting its potential benefits for postmenopausal bone health.
Dietary magnesium supplementation affects bone metabolism and dynamic strength of bone in ovariectomized rats.Toba, Y., Kajita, Y., Masuyama, R., et al.[2018]
In a study of 48,584 postmenopausal women over a median follow-up of 10.1 years, higher daily calcium intake (>400 mg) was linked to a 40-50% reduction in the risk of osteoporotic fractures, particularly in those with a calcium/magnesium intake ratio of โ‰ฅ1.7.
Additionally, high soy isoflavone intake (>42.0 mg/d) was associated with a reduced risk of fractures (HR 0.72) among women with a history of fractures, especially in those who were recently menopausal.
Associations of dietary intakes of calcium, magnesium and soy isoflavones with osteoporotic fracture risk in postmenopausal women: a prospective study.Cui, Y., Cai, H., Gao, Y., et al.[2022]

Citations

Comparative study of the intestinal absorption of three salts of calcium in young and elderly women. [2018]
Dietary magnesium supplementation affects bone metabolism and dynamic strength of bone in ovariectomized rats. [2018]
Associations of dietary intakes of calcium, magnesium and soy isoflavones with osteoporotic fracture risk in postmenopausal women: a prospective study. [2022]
Effect of magnesium supplementation on the fractional intestinal absorption of 45CaCl2 in women with a low erythrocyte magnesium concentration. [2015]
Magnesium intake from food and supplements is associated with bone mineral density in healthy older white subjects. [2013]
The effects of Mg supplementation in diets with different calcium levels on the bone status and bone metabolism in growing female rats. [2013]
Adequacy Rate of Magnesium Citrate Bowel Preparation in a Large Retrospective Cohort. [2022]
Acute biochemical variations induced by two different calcium salts in healthy perimenopausal women. [2019]
Calcium, vitamin D, vitamin K2, and magnesium supplementation and skeletal health. [2020]
Trabecular bone density in a two year controlled trial of peroral magnesium in osteoporosis. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Short-term oral magnesium supplementation suppresses bone turnover in postmenopausal osteoporotic women. [2015]
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