Cardiovascular DiseasesNCT04013776
The Impact of a Low or High Phosphate Diet on Phosphate and Calcium Excretion in Healthy People
A study testing Phosphate supplemented diet in people with Cardiovascular Diseases and Aging, run by Clinical Evaluation Research Unit at Kingston General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Aging, Nutrient; Excess
- What is being tested?
- Phosphate supplemented diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- between ages of 20 and 40
Who cannot join
- known heart disease
- known diabetes
- pregnant
- breast-feeding
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Queen's University
Kingston, Ontario, K7L3V6
Rachel Holden, MD, 613-533-3134, rachel.holdne@kingstonhsc.ca
Corinne Babiolakis, MSc, 613-533-6000 ext. 79579, csb8@queensu.ca
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Aging, Nutrient; Excess
- Being tested
- Phosphate supplemented diet
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphate supplemented dietDietary supplement
Also called sodium phosphate
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
| Study group | Role | What they receive |
|---|---|---|
| Phosphate supplemented diet | Active comparator | All participants will undergo phosphate testing after following a phosphate supplemented diet for 5 days Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary phosphate excretion
Change in urinary phosphate excretion after 500 mg phosphorus challenge
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 May 2017
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013776
- Sponsor's protocol ID
- DMED-2031-17
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Low or High Phosphate Diet on Phosphate and Calcium Excretion in Healthy People
- ClinicalTrials.gov ID
- NCT04013776
- Acronym / sponsor ID
- DMED-2031-17
- Conditions
- Cardiovascular Diseases, Aging, Nutrient; Excess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, cross-over design
| Arm | Type | Receives |
|---|---|---|
| Phosphate supplemented diet | Active comparator | Dietary Supplement: Phosphate supplemented dietAll participants will undergo phosphate testing after following a phosphate supplemented diet for 5 days |
| Low phosphate diet | No intervention | –All participants will undergo phosphate testing after following a low phosphate diet for 5 days |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- between ages of 20 and 40
Key exclusion criteria (4 listed)
- known heart disease
- known diabetes
- pregnant
- breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phosphate supplemented dietAlso: sodium phosphateParticipants 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 | Dietary supplement | Phosphate supplemented diet |
Primary outcome
Urinary phosphate excretion
Time frame: 3 hours
Change in urinary phosphate excretion after 500 mg phosphorus challenge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphate supplemented diet in people with Cardiovascular Diseases and Aging, run by Clinical Evaluation Research Unit at Kingston General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Holden, MD (613-533-3134, rachel.holden@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary phosphate excretion (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.