NCT04013776

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2017

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

July 8, 2019

Last Update Submit

July 10, 2019

Conditions

Cardiovascular DiseasesAgingNutrient; Excess

Outcome Measures

Primary Outcomes (1)

  • Urinary phosphate excretion

    Change in urinary phosphate excretion after 500 mg phosphorus challenge

    3 hours

Study Arms (2)

Phosphate supplemented diet

ACTIVE COMPARATOR

All participants will undergo phosphate testing after following a phosphate supplemented diet for 5 days

Dietary Supplement: Phosphate supplemented diet

Low phosphate diet

NO INTERVENTION

All participants will undergo phosphate testing after following a low phosphate diet for 5 days

Interventions

Phosphate supplemented dietDIETARY_SUPPLEMENT

Participants will be asked to follow a 5 day menu of 750 mg of phosphorus daily along with a daily sodium phosphorus supplement of 500 mg

Also known as: sodium phosphate
Phosphate supplemented diet

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • between ages of 20 and 40

You may not qualify if:

  • known heart disease
  • known diabetes
  • pregnant
  • breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L3V6, Canada

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

sodium phosphate

Central Study Contacts

Rachel Holden, MD

CONTACT

613-533-3134rachel.holden@kingstonhsc.ca

Corinne Babiolakis, MSc

CONTACT

613-533-6000csb8@queensu.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized, cross-over design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine Queen's University

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 10, 2019

Study Start

May 1, 2017

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)