EffCaMgCit for Low Magnesium and Osteoporosis Prevention

Recruiting at 1 trial location

Overseen By Miranda King, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Proton pump inhibitors

Must not be taking: Adrenocorticosteroids, Diuretics, NSAIDs

Disqualifiers: End-stage renal failure, Hypercalcemia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if effervescent calcium magnesium citrate can prevent bone issues and magnesium deficiency in people using proton pump inhibitors (PPIs). PPIs, common for treating stomach problems like heartburn, might weaken bones and lower magnesium levels over time. The trial compares this supplement to a placebo to assess its effectiveness. Ideal candidates are adults who regularly take PPIs, have controlled high blood pressure (under 140/90), and manage Type II diabetes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to research that could lead to a new treatment option.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research on similar calcium and magnesium supplements shows they are generally safe for people. Studies have found that these supplements are easily absorbed by the body and support bone health, making them a good choice for preventing issues like osteoporosis.

However, taking magnesium citrate with certain substances, such as calcium polycarbophil, might slightly increase the risk of mild side effects like dehydration. Although uncommon, these cases are worth considering.

In summary, past studies indicate that effervescent calcium magnesium citrate (EffCaMgCit) is well-tolerated, with few and mostly minor side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Effervescent Calcium Magnesium Citrate (EffCaMgCit) is unique because it combines calcium, magnesium, and citrate in a fizzy, easy-to-dissolve form, which might enhance absorption and effectiveness. Unlike typical oral supplements that can be harsh on the stomach or poorly absorbed, this effervescent delivery system is designed to optimize digestion and uptake in the body. Researchers are excited about this treatment because it targets magnesium deficiency and osteoporosis prevention simultaneously, potentially offering a more comprehensive approach to bone health compared to standard calcium or vitamin D supplements.

What evidence suggests that EffCaMgCit might be an effective treatment for low magnesium and osteoporosis prevention?

This trial will compare Effervescent Calcium Magnesium Citrate (EffCaMgCit) with a placebo. Studies have shown that EffCaMgCit can help prevent bone weakening and magnesium deficiency. Research indicates that EffCaMgCit provides easily absorbed calcium and magnesium, essential for maintaining strong bones and preventing fractures related to osteoporosis. It also helps maintain healthy magnesium levels, which can drop due to certain stomach acid medications. Additionally, EffCaMgCit has been found to lower levels of parathyroid hormone (PTH), which can lead to bone loss if too high. These findings suggest that EffCaMgCit might help prevent some negative effects of long-term proton pump inhibitor use. ^{1 2 5 6 7}

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

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.

Exclusion Criteria

I am on dialysis for end-stage kidney failure.

Your blood phosphate levels are too low.

My blood pressure is very high.

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?

Group I: EffCaMgCit Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

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

Magnesium Citrate (MC) bowel preparation for colonoscopies was found to be highly effective, with adequacy rates of 98.94% for screening and 99.29% for non-screening procedures based on a large sample of 19,173 patients.

MC is a well-tolerated and cost-effective option for bowel preparation, showing favorable results compared to other preparations in this extensive retrospective study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adequacy Rate of Magnesium Citrate Bowel Preparation in a Large Retrospective Cohort. AlSamman, MA., Leung, S., Moustafa, A., et al.[2022]

In a study of 2,038 older adults aged 70 to 79, higher magnesium intake from diet and supplements was linked to increased bone mineral density (BMD) in white men and women, suggesting a potential benefit for bone health.

Specifically, white women had a BMD increase of 0.04 g/cm2 and white men had an increase of 0.02 g/cm2 when comparing the highest to the lowest magnesium intake, while no such association was found in black participants, possibly due to differences in calcium regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium intake from food and supplements is associated with bone mineral density in healthy older white subjects. Ryder, KM., Shorr, RI., Bush, AJ., et al.[2013]

In a study involving 40 female rats over 12 weeks, magnesium (Mg) supplementation with adequate calcium (Ca) significantly improved bone mineral density, size, and metabolism without affecting calcium absorption.

The results indicated that Mg supplementation increased serum osteocalcin and decreased levels of C-telopeptide cross-links of type I collagen, suggesting enhanced bone formation and reduced bone resorption in rats with adequate Ca intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Mg supplementation in diets with different calcium levels on the bone status and bone metabolism in growing female rats. Bae, YJ., Kim, MH.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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 ≥1.7.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 20 healthy women, magnesium supplementation did not significantly affect bone resorption markers or serum parathyroid hormone levels, suggesting it may not directly influence bone health.

However, magnesium supplementation led to a 31.1% increase in urinary magnesium excretion and a significant 23.5% decrease in fractional calcium absorption, indicating that while magnesium is excreted more, it may hinder calcium absorption in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of magnesium supplementation on the fractional intestinal absorption of 45CaCl2 in women with a low erythrocyte magnesium concentration. Basso, LE., Ubbink, JB., Delport, R., et al.[2015]

In a study of 31 postmenopausal women with osteoporosis, magnesium treatment led to a significant increase in bone density after one year, with 71% of participants showing improvements of 1-8%.

Compared to untreated controls, who experienced a significant decrease in bone density, the magnesium-treated group maintained their bone density over two years, suggesting that magnesium may be a beneficial intervention for postmenopausal osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trabecular bone density in a two year controlled trial of peroral magnesium in osteoporosis. Stendig-Lindberg, G., Tepper, R., Leichter, I.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary magnesium supplementation affects bone metabolism and dynamic strength of bone in ovariectomized rats. Toba, Y., Kajita, Y., Masuyama, R., et al.[2018]

Calcium supplementation alone is not recommended for preventing fractures in the general postmenopausal population, but it may benefit those at risk with low dietary intake, requiring personalized approaches to avoid side effects.

Vitamin D supplementation is crucial for individuals at risk of fractures or vitamin D deficiency, while vitamin K2 and magnesium may support bone health, though evidence for their effectiveness remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium, vitamin D, vitamin K2, and magnesium supplementation and skeletal health. Capozzi, A., Scambia, G., Lello, S.[2020]

In a study involving 20 healthy perimenopausal women, calcium citrate (CC) was found to have significantly greater bioavailability compared to calcium gluconolactate and carbonate (CGC), indicating it may be more effective for calcium absorption.

Both calcium salts increased serum calcium levels and urinary calcium excretion while reducing parathyroid hormone levels, but CC's superior absorbability suggests it could be the preferred choice for supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute biochemical variations induced by two different calcium salts in healthy perimenopausal women. Gonnelli, S., Cepollaro, C., Camporeale, A., et al.[2019]

In a study of 20 postmenopausal women, daily oral magnesium supplementation for 30 days significantly decreased serum levels of parathyroid hormone (iPTH), which is important for regulating bone metabolism.

The magnesium-supplemented group also showed increased serum osteocalcin and decreased urinary deoxypyridinoline levels, indicating that magnesium may help suppress bone turnover and improve bone health in postmenopausal women with osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term oral magnesium supplementation suppresses bone turnover in postmenopausal osteoporotic women. Aydin, H., Deyneli, O., Yavuz, D., et al.[2015]

Citations

1. withpower.com withpower.com/trial/effcamgcit-for-low-magnesium-and-osteoporosis-prevention-74c5f

EffCaMgCit for Low Magnesium and Osteoporosis Prevention Trial Overview The study tests if effervescent calcium magnesium citrate can prevent bone weakening, magnesium deficiency, and kidney problems caused by long- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6373382/

Control of metabolic predisposition to cardiovascular ... The goal of this feasibility study was to determine whether effervescent calcium magnesium citrate (EffCaMgCit) ameliorates the aforementioned pathogenic ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30465137/

Control of metabolic predisposition to cardiovascular ... In Stage 5D, EffCaMgCit inhibited formation of CPP, suppressed PTH, and conferred magnesium and alkali loads. These effects were unique, ...

4. data.epo.org data.epo.org/publication-server/rest/v1.0/publication-dates/20200520/patents/EP3653061NWA1/document.pdf

CITRATE-RICH CALCIUM-MAGNESIUM SUPPLEMENT ... The composition also provides soluble calcium and magnesium to prevent oste- oporosis-related fractures and low blood magnesium from the use of ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-3-effervescent-calcium-magnesium-citrate-to-prevent-mineral-metabolism-trial-nct05998863

EffCaMgCit to Prevent Mineral Metabolism and Renal ... The study aims to evaluate if effervescent calcium magnesium citrate (EffCaMgCit) can prevent or treat osteoporosis, magnesium deficiency, and chronic ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/443767

EffCaMgCit to Prevent Mineral Metabolism and Renal ... Each sachet of EffCaMgCit will contain 19 meq or 380 mg calcium, 10 meq (122 mg) magnesium, and 50 meq total citrate. Read more.

7. go.drugbank.com go.drugbank.com/drugs/DB11110

Magnesium citrate: Uses, Interactions, Mechanism of Action The risk or severity of adverse effects can be increased when Magnesium citrate is combined with Calcium polycarbophil. The risk or severity of dehydration can ...