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NCT05998863RECRUITINGIRB Ready

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

Sponsored by University of Texas Southwestern Medical Center

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 56 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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).

Who Can Participate

Inclusion Criteria

Ambulatory adult subjects (\> 21 years of age) of either gender of any ethnicity
Must have taken PPI (omeprazole or equivalent โ‰ฅ 20 mg/day, โ‰ฅ three times per week, for at least 2 months)
Expected to continue at a similar dosage
Stage 1 hypertension (with systolic blood pressure \<140 and diastolic \<90)
Controlled diabetes mellitus Type II with HbA1C less than 7%

Exclusion Criteria

End-stage renal failure on dialysis
Hypercalcemia,
Hypophosphatemia (serum P \< 2.5 mg/dL)
Hypertension stage 2 or higher
Diabetes Type II with HbA1C โ‰ฅ 7%
Treatment with adrenocorticosteroids, diuretics, non-steroidal anti-inflammatory agents - - Regular dose of magnesium supplements, bisphosphonate, teriparatide, denosumab or selective estrogen receptor modulators
Required to take calcium Inclusion/exclusion of other drugs or conditions will be considered on an individual basis.

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

56 participants

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Age Range

21 Years - 99 Years

โšง

Gender

ALL

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Sponsor

University of Texas Southwestern Medical Center

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Dallas

Texas

Location available
View Dallas location page
RECRUITING

Dallas

Texas

Location available
View Dallas location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Bone mineral density Treatment in Dallas?

Join others in Texas exploring innovative treatment options through clinical research

Bone mineral density Treatment Options in Dallas, Texas

If you're searching for Bone mineral density treatment in Dallas, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Dallas, Dallas and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Bone mineral density. All study-related care is provided at no cost to participants.

Local Sites
2 locations in Texas
Now Enrolling
Up to 56 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Bone mineral density?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Bone mineral density

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Bone mineral density Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05998863. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.