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

NCT02020785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-06-05

Study results available
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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.

Conditions

Interventions

OTHER

Higher phosphorus period

Commercially-available unaltered food/beverage products containing phosphorus additives (\~1gm/d of phosphorus) will be given for 3 weeks. All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.

OTHER

Lower phosphorus period

Commercially-available unaltered food/beverage products without phosphorus additives (\<10mg/d of phosphorus) will be given for 3 weeks. All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of \~1gm/d by receiving education on avoiding phosphorus-based additives.

Sponsors & Collaborators

Principal Investigators

  • Alex R Chang, MD, MS · Geisinger Clinic

  • Lawrence J Appel, MD, MPH · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02020785 on ClinicalTrials.gov