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

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ClinicalTrials.gov Identifier: NCT05998863
Recruitment Status : Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Khashayar Sakhaee, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
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). The current trial represents the investigators ongoing effort to discern whether these complications could be averted by effervescent calcium magnesium citrate (EffCaMgCit).

Condition or disease Intervention/treatment Phase
Osteoporosis Hypomagnesemia Drug: EffCaMgCit Other: Placebo Phase 3

Detailed Description:

In the current proposal, the investigators wish to conduct a 1-year treatment trial, directed at obtaining more definitive evidence that EffCaMgCit overcomes all three complications of PPI.

Aim 1. To test the hypothesis that EffCaMgCit would prevent/treat osteoporosis, by suppressing parathyroid function and bone resorption, thereby stabilizing bone mineral density (BMD). The critical endpoint will be overall change in BMD T-Score and Z-Score from baseline to the end of study. Secondary endpoints will be the change in serum PTH and C-terminal telopeptide (CTX).

Aim 2. To test the hypothesis that EffCaMgCit would prevent/treat hypomagnesemia/magnesium deficiency, by providing bioavailable magnesium. The critical endpoint will be the overall change in the fractional excretion of magnesium (FEMg) and free muscle magnesium by MRS from baseline to the end of study. Secondary endpoints will be the change in serum and urinary magnesium.

Aim 3. To test the hypothesis that EffCaMgCit would reduce the risk of CKD during PPI use by averting putative hypomagnesemia/magnesium deficiency and neutralizing acid load. The investigators propose that PPI causes hypomagnesemia/magnesium deficiency and confers an acid load, - factors implicated for incident CKD and its progression. EffCaMgCit is expected to avert incident CKD by providing bioavailable magnesium and alkali load. Critical endpoints will be the overall change in endogenous creatinine clearance, urinary alpha-1 microglobulin, and a measure of acid-base status.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: To provide adequate blinding, each medication sachet will be labelled with the study name, IRB number, principal investigator's name, expiration date and identification number of the study subject. Labels will be applied to the appropriate medication sachets once the subject has been randomized and assigned to a treatment group. Labelling of the sachets will be done by personnel who are not engaged in patient care.
Primary Purpose: Treatment
Official Title: Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of Chronic Proton Pump Inhibitor Therapy
Estimated Study Start Date : April 15, 2024
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EffCaMgCit
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.
 Drug: EffCaMgCit
Each sachet of EffCaMgCit will contain 19 meq or 380 mg calcium, 10 meq (122 mg) magnesium, and 50 meq total citrate.
Other Name: Effervescent calcium magnesium citrate
Placebo Comparator: Placebo
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.
 Other: Placebo
Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Bone Mineral Density (BMD) T-Score at 1 Year [ Time Frame: Baseline and 1 year ]
    Change in Bone Mineral Density (BMD) T-Score from baseline to 1 Year as measured by dual photon absorptiometry. The range, as defined by the World Health Organization (WHO), for T-Score is: -1 and above = Normal, Between -1 and -2.5 = Osteopenia, -2.5 and below = osteoporosis.

  2. Change From Baseline in the Fractional Excretion of Magnesium (FEMg) at 1 Year [ Time Frame: Baseline and 1 year ]
    Change From Baseline in the Fractional Excretion of Magnesium (FEMg) at 1 Year as measured by the ratio of magnesium clearance and creatinine clearance, using 24-h urinary magnesium and creatinine and corresponding serum magnesium and creatinine obtained post meal/load.

  3. Change from baseline in endogenous creatinine clearance at 1 year. [ Time Frame: Baseline and 1 year ]
    Change from baseline in endogenous creatinine clearance at 1 year. Endogenous creatinine clearance will be obtained by using 24-h urinary creatinine and post-meal/load venous blood sample ((uCr, mg/24hr) / (sCr, mg/dL * 14.4)) as well as using the Cockcroft and Gault formula ([(140 - age) x TBW] / (Scr x 72) (x 0.85 for females)).

  4. Change From Baseline in Bone Mineral Density (BMD) Z-Score at 1 Year [ Time Frame: Baseline and 1 year ]
    Change From Baseline in Bone Mineral Density (BMD) Z-Score at 1 Year as measured by dual photon absorptiometry. Outcome is considered positive if the Z Score after one year of treatment becomes less negative (less than -2). There is no specific score range for the Z Score.

  5. Change From Baseline in Free Muscle Magnesium at 1 Year [ Time Frame: Baseline and 1 year ]
    Change From baseline in free muscle magnesium at 1 year as assessed by measuring intracellular Mg in a calf muscle, by using 31P (Phosphorous) magnetic resonance spectroscopy (MRS).


Secondary Outcome Measures :
  1. Change in Serum Parathyroid Function (PTH) [ Time Frame: Baseline and 1 year ]
    Change from baseline in serum parathyroid function (PTH) at 1 year will be measured by Biomerica Intact-PTH ELISA.

  2. Change in C-terminal telopeptide (CTX) [ Time Frame: Baseline and 1 year ]
    Change from baseline in serum bone resorption marker C-terminal telopeptide (CTX) at 1 year will be measured by lab finding utilizing ELISA CTX-I (CrossLaps).

  3. Change in Serum Magnesium [ Time Frame: Baseline and 1 year ]
    Change from baseline in serum magnesium at 1 year will be measured by ion selective electrode.

  4. Change in Urine Magnesium [ Time Frame: Baseline and 1 year ]
    Change from baseline in urine magnesium at 1 year measured by atomic absorption.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998863


Contacts
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Contact: Khashayar Sakhaee, MD 214-648-0324 Khashayar.Sakhaee@UTSouthwestern.edu
Contact: Miranda King, MPH 214-648-2117 Miranda.King@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9107
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Khashayar Sakhaee, MD UTSW
More Information
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Responsible Party: Khashayar Sakhaee, Professor, Internal Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05998863    
Other Study ID Numbers: STU-2023-0340
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Khashayar Sakhaee, University of Texas Southwestern Medical Center:
Bone mineral density
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Magnesium citrate
Cathartics
Gastrointestinal Agents