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Clinical Trials/NCT04013776
NCT04013776
Unknown
Not Applicable

The Impact of a Low or High Phosphate Diet on Phosphate and Calcium Excretion in Healthy People

Clinical Evaluation Research Unit at Kingston General Hospital1 site in 1 country20 target enrollmentMay 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Enrollment
20
Locations
1
Primary Endpoint
Urinary phosphate excretion
Last Updated
6 years ago

Overview

Brief Summary

Phosphate is present in many of the foods that the investigators eat and is required by many cellular processes. The kidneys are the only organ that excrete the extra phosphate from the diet that the body does not require. Phosphate is linked to vascular calcification and cardiovascular disease. Measures of serum phosphate do not reflect the burden of phosphate and are not sensitive to early changes in the way the kidneys eliminate phosphate. This study will determine whether the kidneys handle an oral phosphate load differently after 5 days of a low phosphate diet compared to 5 days of a high phosphate diet.

Detailed Description

In this study, participants will follow a low-phosphorus diet (750 mg) with a 500 mg calcium supplement for 5 days keeping a detailed diary of the foods eaten during this period. On the 5th day, the participant will undergo a 24 hour urine collection. Participants will present after an overnight fast for baseline blood and urine measurements. Then they will consume water containing 500 mg of phosphorus. Urine and blood will be collected every hour for 3 hours for measurement of phosphate and calcium and for measurement of hormones known to regulate phosphate and calcium including fibroblast growth factor-23, parathyroid hormone and vitamin D. One week later, participants will follow the same diet but will also receive a 1250 mg phosphorus supplement for 5 days. On the 5th day, urine will be collected for 24 hours. Participants will present again after an overnight fast and undergo the identical testing.

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. Rachel Holden

Professor of Medicine Queen's University

Clinical Evaluation Research Unit at Kingston General Hospital

Eligibility Criteria

Inclusion Criteria

  • between ages of 20 and 40

Exclusion Criteria

  • known heart disease
  • known diabetes
  • breast-feeding

Outcomes

Primary Outcomes

Urinary phosphate excretion

Time Frame: 3 hours

Change in urinary phosphate excretion after 500 mg phosphorus challenge

Study Sites (1)

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