Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05998863
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-08-03
Brief Title:
EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of Chronic Proton Pump Inhibitor Therapy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 preventtreat 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 preventtreat hypomagnesemiamagnesium 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 hypomagnesemiamagnesium deficiency and neutralizing acid load The investigators propose that PPI causes hypomagnesemiamagnesium 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
Aim 1 To test the hypothesis that EffCaMgCit would preventtreat 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 preventtreat hypomagnesemiamagnesium 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 hypomagnesemiamagnesium deficiency and neutralizing acid load The investigators propose that PPI causes hypomagnesemiamagnesium 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None