CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Higher phosphorus period +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02020785
NCT02020785N/ACompleted

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

Geisinger Clinic·interventional·Posted Dec 25, 2013·Updated Jun 5, 2019

In Brief

A clinical study evaluating Higher phosphorus period and Lower phosphorus period for Albuminuria. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlbuminuria
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 25, 2013
Enrollment StartJan 1, 2014
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.5 years ago

Interventions

Higher phosphorus periodother

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.

Lower phosphorus periodother

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.