Status:
SUSPENDED
The Impact of Phosphate Metabolism on Healthy Aging
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Hypophosphatemia
Rickets
Eligibility:
All Genders
13+ years
Phase:
EARLY_PHASE1
Brief Summary
Determine the association between duration and dose of chronic conventional therapy with Pi and renal (nephrocalcinosis/nephrolithiasis), vascular (endothelial function), and cardiovascular function (...
Detailed Description
The central hypothesis of this proposal is that patients with X-linked hypophosphatemia (XLH), when matched for duration and dose of phosphate (Pi) therapy to patients with hereditary hypophosphatemic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03771105
Start Date
January 1 2019
End Date
April 1 2026
Last Update
May 23 2025
Active Locations (1)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06511