RecruitingNot ApplicableNCT07368946

Phosphate Assessment in Chronic Kidney Disease Patients Study

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

Sponsor

University of Texas Southwestern Medical Center

Enrollment

60 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease (Stage 3-4)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well current methods estimate phosphate intake from food in people with moderate chronic kidney disease (CKD stages 3 and 4), where managing phosphate levels is important to protect kidney and bone health. **You may be eligible if...** - You are 18 years or older, any race or ethnicity - You are a post-menopausal woman or a man without a monthly menstrual cycle - You have CKD Stage 3 or 4 (eGFR between 15 and 60), OR you have normal kidney function without protein in your urine (as a comparison participant) - You consume between 1700 and 2700 calories per day - You speak English **You may NOT be eligible if...** - You are pregnant, breastfeeding, or less than 3 months postpartum - You are on dialysis or have had a kidney transplant - You use insulin or chemotherapy - You smoke, vape, or use other nicotine/recreational drugs - You have a history of stroke or heart attack Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTDietary Phosphorus Intake

Dietary phosphorus intake of about 777 mg/day for 7 days, followed by an increase to about 1,277mg/day for another 7 days, and a further increase to about 1,777 mg/day for the subsequent 7 days. The meal plan will maintain consistent intake of calories, sodium, potassium, and calcium throughout the 21-day intervention. 1200 mg/day and 1700 mg/day phosphorus diets will be achieved by providing participants with sodium phosphate capsules and 777 mg/day meals.

Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT07368946

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