Pilot Study on Phosphate Overload in Adults With and Without Chronic Kidney Disease Assessing Dietary Phosphorus Effects on Blood Biomarkers Over 21 Days

What this Trial Is About

This research aims to explore new pathways in phosphate metabolism and identify novel biomarkers for phosphate overload, especially in people with chronic kidney disease CKD. The study seeks to understand how CKD affects these metabolic pathways and to develop a reliable index to measure phosphate overload based on dietary intake. The goal is to provide preliminary data that could help improve early interventions and health outcomes for CKD patients. The study will include 60 participants, 30 with CKD and 30 without, who will follow a 21-day diet with gradually increasing phosphorus intake. For the first 7 days, participants consume about 777 mgday of phosphorus, then increase to about 1,277 mgday for the next 7 days, and finally to about 1,777 mgday for the last 7 days. Sodium phosphate capsules and controlled meals will be used to maintain consistent intake of calories, sodium, potassium, and calcium throughout the study. Participants will provide overnight fasting blood samples and 24-hour and random urine samples at the start and end of each diet phase to measure changes in phosphate, parathyroid hormone, fibroblast growth factors, calcium, vitamin D, and other related biomarkers. The study will monitor these measures weekly over three weeks to assess phosphate overload and related metabolic changes. The total study duration per participant is 21 days, focusing on detailed metabolic assessments.

Phosphate Assessment in Chronic Kidney Disease Patients Study