Study of Dietary Phosphate and Mineral Homeostasis in Early Chronic Kidney Disease

Kidney Diseases Clinical Trial

Official title: Study of Dietary Phosphate and Mineral Homeostasis in Early Chronic Kidney Disease

Status Completed

Clinical Trial Summary

This study is designed to describe the physiological response to increased and decreased dietary phosphate intake on various parameters of mineral metabolism in the blood and urine of individuals with Chronic Kidney Disease stage 3 and 4 with normal serum phosphate levels. This detailed study will give us a far greater understanding of the role of diet in abnormal mineral homeostasis early in the progression of this chronic disease. The findings of this study will help both physicians and dietitians better determine the optimal time to introduce dietary therapy in CKD.

Clinical Trial Description

The potential benefits of implementation of phosphate management earlier in CKD (Stages 3/4) are threefold: 1) prevention of vascular damage early in the progression of CKD thus reducing risk of cardiovascular death 2) Improved management of renal bone disease and resultant co-morbidities and 3) slowing the progression of renal failure lengthening the time required till dialysis is required. Although dietary counseling is currently a normal part of CKD care, the utility and effectiveness of lowering phosphate has not previously been quantified. In part this is due to the difficulty of measurement of serum phosphate as it is so tightly controlled before GFR falls below 30mls/min. No studies have investigated whether is it possible to modulate circulating FGF-23 and phosphate excretion in early stages of renal failure using diet in individuals with normal serum phosphate levels.

Study Objectives ;

1. To measure FGF-23 levels before and after a high phosphate diet, low phosphate diet and a low phosphate diet with phosphate binders.

2. To measure levels of calcium, phosphate, PTH, 25 and 1,25 vitamin D and fractional phosphate excretion before and after a high phosphate diet, low phosphate diet and a low phosphate diet with phosphate binders. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT00755690
• Study type: Interventional
• Source: University of British Columbia
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Completion date: March 2010