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EffCaMgCit for Low Magnesium and Osteoporosis Prevention

Phase 3

Recruiting

Led By Khashayar Sakhaee, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have taken PPI (omeprazole or equivalent ≥ 20 mg/day, ≥ three times per week, for at least 2 months) and expected to continue at a similar dosage

Controlled diabetes mellitus Type II with HbA1C less than 7%

Must not have

End-stage renal failure on dialysis

Hypertension stage 2 or higher

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 year

Awards & highlights

Pivotal Trial

Summary

This trial studies if taking EffCaMgCit can help reduce risk of fractures, magnesium deficiency & CKD caused by taking PPIs for conditions like GERD, ulcers & heartburn.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include digestive discomfort such as bloating or gas due to the effervescence of the supplement, as well as imbalances in mineral levels like high calcium (hypercalcemia), although specific side effect profiles are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been taking a strong acid reducer regularly for at least 2 months and will continue.

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My Type II diabetes is under control with an HbA1C below 7%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis for end-stage kidney failure.

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My blood pressure is very high.

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My diabetes type 2 is not well-controlled (HbA1C is 7% or higher).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Bone Mineral Density (BMD) T-Score at 1 Year

Change From Baseline in Bone Mineral Density (BMD) Z-Score at 1 Year

Change From Baseline in Free Muscle Magnesium at 1 Year

+2 more

Secondary study objectives

Change in C-terminal telopeptide (CTX)

Change in Serum Magnesium

Change in Serum Parathyroid Function (PTH)

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EffCaMgCitExperimental Treatment1 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: PlaceboPlacebo Group1 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.

0 / 5Eligibility criteria met