Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of Phosphate Metabolism on Healthy Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03771105
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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).

Condition or disease Intervention/treatment Phase
Hypophosphatemia Hypophosphatemic Rickets Hypercalciuria Drug: phosphate Early Phase 1

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 rickets with hypercalciuria (HHRH), will evidence greater cardiovascular and vascular debility than patients with HHRH. The overall objectives of this project are to utilize our existing longitudinal databases for individuals with XLH and HHRH through an interdisciplinary collaboration between pediatric and adult endocrinology to: i) quantify the impact of exposure to Pi therapy across the lifespan on cardiovascular and renal complications, which are key aging endpoints, ii) determine the acute response to Pi loading in XLH and HHRH by studying the changes in surrogate markers of cardiovascular and renal function.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: crossover parallel
Primary Purpose: Treatment
Official Title: The Impact of Phosphate Metabolism on Healthy Aging
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020


Arm Intervention/treatment
Experimental: Patients with hereditary hypophosphatemic rickets with HHRH
Hereditary hypophosphatemic rickets with hypercalciuria (HHRH)
Drug: phosphate
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.

Active Comparator: Patients with X-linked Hypophosphatemia
Patients with X-linked hypophosphatemia
Drug: phosphate
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.

Active Comparator: 15 Patients with X-linked Hypophosphatemia
15 Patients with X-linked Hypophosphatemia that will receive phosphate treatment for 30 days.
Drug: phosphate
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.

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.
Drug: phosphate
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.




Primary Outcome Measures :
  1. Parathyroid Hormone (PTH) levels [ Time Frame: 30 days ]
    PTH levels are expected to increase over baseline after phosphate supplement (Pi) washout.

  2. Fibroblast Growth Factor 23 (FGF23) levels [ Time Frame: 30 days ]
    FGF23 levels are expected to increase over baseline after phosphate supplement (Pi) washout.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771105


Contacts
Layout table for location contacts
Contact: Clemens Bergwitz, MD 203-737-5450 clemens.bergwitz@yale.edu

Sponsors and Collaborators
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Clemens Bergwitz, MD Yale University

Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03771105     History of Changes
Other Study ID Numbers: Bergwitz_10.22.18
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypophosphatemia
Rickets
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Hypercalciuria
Phosphorus Metabolism Disorders
Metabolic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Urological Manifestations
Signs and Symptoms