NCT03771105 The Impact of Phosphate Metabolism on Healthy Aging
| NCT ID | NCT03771105 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Yale University |
| Condition | Hypophosphatemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2019-01-01 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (echo- cardiography) in patients with hereditary hypophosphatemic rickets with hypercalciuria (HHRH) and patients with X-linked hypophosphatemia (XLH).
Eligibility Criteria
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.
Contact & Investigator
Clemens Bergwitz, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT03771105 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Hypophosphatemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03771105 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03771105 currently recruiting?
Yes, NCT03771105 is actively recruiting participants. Contact the research team at clemens.bergwitz@yale.edu for enrollment information.
Where is the NCT03771105 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT03771105 clinical trial?
NCT03771105 is sponsored by Yale University. The principal investigator is Clemens Bergwitz, MD at Yale University. The trial plans to enroll 30 participants.