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A Pilot Feeding Study to Assess Phosphate Overload in Patients With Chronic Kidney Disease

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability. Investigators will address the following specific aims: 1). To explore novel pathways of phosphate metabolism and assess the influence of CKD status on these metabolic pathways. 2). To identify novel biomarkers for phosphate overload that reflect changes in dietary phosphorus intake. 3). To develop a compound phosphate overload index that measures dietary phosphorus intake with high validity and reliability. This study will provide novel insights into phosphate metabolism and the assessment of phosphate overload in CKD patients. This investigation aims to provide preliminary data to further studies for the development of reliable biomarkers in CKD patients, which could contribute significantly to early interventions and improve health outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Men or women aged 18 years or older, of any race/ethnicity

• Women must either be post-menopausal or have no monthly menstrual cycle

• Estimated total daily energy expenditure (TDEE) of 1700 - 2700 calories

• eGFR \>15 ml/min/1.73m2 - \< 60 ml/min/1.73m2 for the CKD group (CKD Stage 3 or Stage 4)

• eGFR ≥ 60 ml/min/1.73m2 and negative urine protein on dipstick test for the non-CKD group

• English speaking

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Alexandra Hartman
pack.utsw@utsouthwestern.edu
214-645-8294
Backup
Paola Lanza, MD
paola.lanza@utsouthwestern.edu
469-852-9550
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Chronic Kidney Disease Patients
Participants with eGFR \>15 ml/min/1.73m2 - \< 60 ml/min/1.73m2 for the CKD group
Active_comparator: Control Group
Healthy participants without CKD eGFR ≥ 60 ml/min/1.73m2
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov