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Could a simple supplement shield bones and kidneys from common heartburn drugs?

NCT ID NCT05998863

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial investigates whether a daily effervescent supplement containing calcium, magnesium, and citrate can prevent bone loss, magnesium deficiency, and kidney damage in adults who take proton pump inhibitors (PPIs) long-term for conditions like heartburn or GERD. Participants must be over 21, have taken PPIs for at least two months, and have controlled blood pressure or type 2 diabetes. The study compares the supplement to a placebo over one year, measuring changes in bone density, magnesium levels, and kidney function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Effervescent calcium magnesium citrate
What this could lead to
If it works, this supplement could help prevent osteoporosis, magnesium deficiency, and kidney problems in people who need long-term acid-reducing medication.
What could go wrong
This is a Phase 3 trial, but it is still testing whether the supplement works for these purposes. Results may not apply to everyone, and the supplement may cause side effects like digestive upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Started

Apr 2024

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ambulatory adult subjects (\> 21 years of age) of either gender of any ethnicity * Must have taken PPI (omeprazole or equivalent ≥ 20 mg/day, ≥ 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 ≥ 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9107, United States

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