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EffCaMgCit for Low Magnesium and Osteoporosis Prevention

Phase 3

Waitlist Available

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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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%.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in C-terminal telopeptide (CTX)

Change in Serum Magnesium

Change in Serum Parathyroid Function (PTH)

+1 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,743 Total Patients Enrolled

2 Trials studying Osteoporosis

162 Patients Enrolled for Osteoporosis

Khashayar Sakhaee, MDPrincipal InvestigatorUTSW

4 Previous Clinical Trials

176 Total Patients Enrolled

1 Trials studying Osteoporosis

62 Patients Enrolled for Osteoporosis

Media Library

Effervescent Calcium Magnesium Citrate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05998863 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals admitted into this research endeavor?

"Patients eligible for this trial must be aged 21 or above, with no upper limit of 99."

Answered by AI

Am I eligible to be included in this clinical research?

"Qualified participants for this research must be between 21 and 99 years old, suffer from osteoporosis, and register as one of the 56 eligible enrollees."

Answered by AI

Are new participants able to join the current clinical trial?

"Per the details on clinicaltrials.gov, this trial has concluded its participant recruitment phase. The study was initially posted on October 1st 2023 and last updated August 10th 2023; however, at present there are 141 other trials actively seeking volunteers."

Answered by AI

Is EffCaMgCit a viable and secure treatment option for individuals?

"The safety of EffCaMgCit has been assessed as a 3 on our company's 1-3 scale, due to the Phase 3 trial results that substantiate its efficacy and validate prior studies regarding its security."

Answered by AI

What results are investigators hoping to attain from this trial?

"This clinical trial evaluates Change From Baseline in the Fractional Excretion of Magnesium (FEMg) over a 12-month period as its primary outcome. Secondary outcomes, to be assessed at 1 year using ELISA CTX-I (CrossLaps), an ion selective electrode and atomic absorption respectively, are focused on changes in C-terminal telopeptide (CTX), serum magnesium, and urine magnesium levels."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Khashayar Sakhaee 2024. "EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05998863.

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