Recruiting

Biomarkers

Sponsor:

University of Florida

Code:

NCT07056283

Conditions

Hypomagnesemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

In this pilot exploratory study, we aim to examine extracellular vesicles (EVs) as biomarkers in urine from up to 15 patients, with up to 10 samples per patient among the patients with a history of hypomagnesemia.

Conditions

Hypomagnesemia

Study ID

NCT07056283

Start date

Jul 31, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (≥18 years old)
  • History of hypomagnesemia (serum Mg <1.7 mg/dL)

Exclusion Criteria:

  • Current or recent use of loop, thiazide, or thiazide-like diuretics within the last 3 months

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Hypomagnesemia (serum Mg <1.7 mg/dL)

The patients will be selected with a history of hypomagnesemia. The urine samples will be collected at various intervals depending on the most recent serum magnesium levels available during the study period. The patients may or may not be on medications known to alter serum magnesium levels.

Primary outcome measure

  • Changes in urinary markers pNKCC2/NKCC2, pNCC/NCC, pSPAK/SPAK, uEGF/Cr, TRPM6, Uromodulin [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Chintan Shah, MD

(352) 294-8790shahc@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Chintan Shah, MD

325-273-8821shahc@ufl.edu

shahc@ufl.edu

Principal Investigator:

Chintan Shah, MD

More Information

Sponsor

University of Florida

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Keywords

  • Hypomagnesemia
  • Magnesium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-08-24.