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

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ClinicalTrials.gov Identifier: NCT04013776
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Aging Nutrient; Excess Dietary Supplement: Phosphate supplemented diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, cross-over design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Impact of a Low or High Phosphate Diet on Phosphate and Calcium Excretion in Healthy People
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Active Comparator: Phosphate supplemented diet
All participants will undergo phosphate testing after following a phosphate supplemented diet for 5 days
Dietary Supplement: Phosphate supplemented diet
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
Other Name: sodium phosphate

No Intervention: Low phosphate diet
All participants will undergo phosphate testing after following a low phosphate diet for 5 days



Primary Outcome Measures :
  1. Urinary phosphate excretion [ Time Frame: 3 hours ]
    Change in urinary phosphate excretion after 500 mg phosphorus challenge



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • between ages of 20 and 40

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013776


Contacts
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Contact: Rachel Holden, MD 613-533-3134 rachel.holden@kingstonhsc.ca
Contact: Corinne Babiolakis, MSc 613-533-6000 ext 79579 csb8@queensu.ca

Locations
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Canada, Ontario
Queen's University Recruiting
Kingston, Ontario, Canada, K7L3V6
Contact: Rachel Holden, MD    613-533-3134    rachel.holdne@kingstonhsc.ca   
Contact: Corinne Babiolakis, MSc    613-533-6000 ext 79579    csb8@queensu.ca   
Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital

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Responsible Party: Dr. Rachel Holden, Professor of Medicine Queen's University, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT04013776     History of Changes
Other Study ID Numbers: DMED-2031-17
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiovascular Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs