Health TrialsbyHealthPanel

The Impact of Phosphate Metabolism on Healthy Aging

ConditionsHypophosphatemiaRicketsHypercalciuriaXLHHHRH
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age13+
SponsorYale University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • phosphate

    Drug

    The target daily phosphate (Pi) intake is 3,500 mg/day (dietary intake plus our supplementation) for this study. Subjects will take a supplement of Pi (as KPhos Neutral 250 mg/tablet) to reach this target. Subjects will receive treatment for 30 days.

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: Patients with hereditary hypophosphatemic rickets with HHRHExperimental treatment 1 intervention
Group B: Patients with X-linked HypophosphatemiaActive comparator 1 intervention
Group C: 15 Patients with X-linked HypophosphatemiaActive comparator 1 intervention
Group D: 15 Patients Hereditary hypophosphatemic rickets with HHRHActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Parathyroid Hormone (PTH) levels

PTH levels are expected to increase over baseline after phosphate supplement (Pi).

Time frame
30 days
2

Fibroblast Growth Factor 23 (FGF23) levels

FGF23 levels are expected to increase over baseline after phosphate supplement (Pi).

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Source ClinicalTrials.gov
Apply now