N/A
N=31
Study of Dietary Additive Phosphorus on Proteinuria and Fibroblast Growth Factor-23
Albuminuria
Bottom Line
View on ClinicalTrials.gov: NCT02020785 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: 24-hour Urine Albumin Excretion — 86.2; 76.4 mg/day — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Higher phosphorus period (Other); Lower phosphorus period (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Geisinger Clinic
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hour Urine Albumin Excretion |
86.2; 76.4 | 0.05 |
| PRIMARY Fibroblast Growth Factor-23 (FGF-23) |
132.6; 128.2 | 0.05 |
| SECONDARY Systolic Blood Pressure |
126.9; 128 | 0.05 |
| SECONDARY Diastolic Blood Pressure |
69.3; 70.2 | 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
Adults at least 21 years of age with at least microalbuminuria
Exclusion Criteria
Estimated glomerular filtration rate <45ml/min/1.73m2, poorly controlled diabetes or hypertension, nephrotic syndrome, hyperparathyroidism, Paget's Disease, multiple myeloma, uncontrolled thyroid disease, chronic antacid use, use of phosphorus binders, phosphorus supplements, or high-dose vitamin D, inability to complete feeding study, investigator discretion
Data sourced from ClinicalTrials.gov (NCT02020785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.