The Impact of Phosphate Metabolism on Healthy Aging (NCT03771105) | Clinical Trial Compass
SuspendedEarly Phase 1
The Impact of Phosphate Metabolism on Healthy Aging
Stopped: lack of funding
United States30 participantsStarted 2019-01-01
Plain-language summary
Determine the association between duration and dose of chronic conventional therapy with Pi and renal (nephrocalcinosis/nephrolithiasis), vascular (endothelial function), and cardiovascular function (echo- cardiography) in patients with hereditary hypophosphatemic rickets with hypercalciuria (HHRH) and patients with X-linked hypophosphatemia (XLH).
Who can participate
Age range13 Years
SexALL
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Inclusion Criteria:
* Children above the age of 13 years
* Younger and older adults with XLH and HHRH with confirmed NPT2c mutations affecting both copies of the NPT2c gene (HHRH) or one copy of the PHEX gene (XLH)
* Be willing to provide access to prior medical records to determine eligibility including imaging, biochemical, medical, and surgical history data
* Be willing and able to complete all aspects of the study
* Be willing to adhere to the study visit schedule and comply with the assessments (in the opinion of the investigator).
Exclusion Criteria:
* Subjects will be excluded, if they are children younger than age 13 years
* Subjects that have other diseases likely to impact bone and mineral metabolism (e.g. renal, hepatic, gastrointestinal disorders, and malignancy),
* Subjects that are currently pregnant,
* Subjects that received medical therapy or developed any condition, which in the opinion of the investigator, could present a concern for either subject safety or difficulty with data interpretation.
* Subjects will be excluded from Aim 2, if they are unable to tolerate supplemental phosphate.