Study of Dietary Additive Phosphorus on Proteinuria and Fibroblast Growth Factor-23 — SODA-POP  

Albuminuria Clinical Trial

Official title: Randomized Cross-over Study Examining the Effects of Phosphorus Additives on Urinary Albumin Excretion and Fibroblast Growth Factor-23

Status Completed

Clinical Trial Summary

Phosphorus-based food additives are commonly used by food manufacturers for many applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these additives can significantly increase an individual's daily phosphorus intake, little is known about the effect of dietary phosphorus on kidney health. In this study, the investigators will first lower baseline phosphorus intake to about 1000mg/d by educating participants to avoid foods with phosphorus additives. Then, participants will be randomized to a higher phosphorus period (~2gm/d) and a lower phosphorus period (~1gm/d) by providing unaltered, commercially-available food/beverage products with and without phosphorus additives.

The investigators hypothesize that participants will have higher urine albumin excretion and fibroblast growth factor-23 (FGF-23) during the higher phosphorus period compared to the lower phosphorus period.

Clinical Trial Description

The Study of Dietary Additive Phosphorus on Proteinuria and FGF-23 (SODA-POP) was a single-center, randomized, double-blind, two-period cross-over study that examined the effect of higher vs. lower phosphorus intake for 3 week periods, achieved by addition of commercially available diet beverages and breakfast bars to diet on albuminuria and fibroblast growth factor 23, in adults with presumed early chronic kidney disease (estimated glomerular filtration rate >= 45 ml/min/1.73m2; and urine albumin/creatinine ratio >=17 mg/g for men or >=25 mg/g for women). ;

Related Conditions & MeSH terms

• Albuminuria
• Proteinuria

• NCT number: NCT02020785
• Study type: Interventional
• Source: Geisinger Clinic
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: September 2015