The Impact of Phosphate Metabolism on Healthy Aging

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT03771105
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • HHRH
  • Hypercalciuria
  • Hypophosphatemia
  • Rickets
  • XLH

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Jan 1, 2019
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with hereditary hypophosphatemic rickets with HHRH
    Hereditary hypophosphatemic rickets with hypercalciuria (HHRH)
  • Active Comparator: Patients with X-linked Hypophosphatemia
    Patients with X-linked hypophosphatemia
  • Active Comparator: 15 Patients with X-linked Hypophosphatemia
    15 Patients with X-linked Hypophosphatemia that will receive phosphate treatment for 30 days.
  • Active Comparator: 15 Patients Hereditary hypophosphatemic rickets with HHRH
    15 patients withHereditary hypophosphatemic rickets with hypercalciuria (HHRH) that will receive phosphate treatment for 30 days.

Primary Outcome Measure

Parathyroid Hormone (PTH) levels [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06511
Clemens Bergwitz, M.D.
[email protected]
203-737-5450

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Yale University School of Medicine· New Haven, CT

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