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NCT00356512 · ClinicalTrials.gov registry record
Physiologic Regulation of FGF-23
A clinical trial, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- 20
- Enrollment target
NCT00356512 is a clinical trial that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 20 participants.
The verdict
NCT00356512 has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
This study will explore the regulation of fibroblast growth factor-23 (FGF-23). It is a hormone recently identified as a regulator of the blood levels of phosphorus and vitamin D, both of which are essential for overall health and especially important for bone health. The parathyroid hormone (PTH) regulates phosphorus and calcium, but people with hypoparathyroidism or pseudohypoparathyroidism do not have sufficient PTH action. There are genetic diseases that influence FGF-23, causing abnormal metabolism of phosphorus and vitamin D, thus affecting the bones. Also, there are rare tumors that may cause overproduction of FGF-23 causing debilitating bone disease. Patients ages 18 and older who have low PTH levels, or are resistant to PTH action, and take calcitriol and calcium supplements, who are not pregnant, and who do not have kidney disorders may be eligible for this study. During the 4-day study, patients will be provided with a controlled diet that has a lower than usual phosphorus content. On day 1, patients will be admitted to the NIH Clinic Center and undergo blood and urine tests to measure calcium, phosphorus, vitamin D, and FGF-23. They will continue with their regular medicine for hypoparathyroidism. On that day and throughout the study, patients will fast from 10:00 p.m. to 8:00 a.m. the following day. On day 2, patients will continue fasting until 4:00 p.m. A tube will be placed in the vein of each arm: one for drawing blood and the other for infusing calcium. Just one intravenous (IV) line will be used on the other days. Patients will receive calcium chloride for 8 hours, at a dose carefully monitored by a machine. The purpose is to bring the blood calcium level to the high normal range or just above. Blood and urine samples will be collected periodically, to check for effects of calcium chloride on FGF-23 and PTH. On days 3 and 4, patients will not take calcitriol and calcium but will receive injections of PTH, under the skin, two times each day. On da
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-07-19 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00356512
The ClinicalTrials.gov registry entry for NCT00356512 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00356512 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00356512 about?
NCT00356512 is a clinical study titled "Physiologic Regulation of FGF-23". This study will explore the regulation of fibroblast growth factor-23 (FGF-23). It is a hormone recently identified as a regulator of the blood levels of phosphorus and vitamin D, both of which are essential for overall health and especially important for bone health. The parathyroid hormone (PTH) r...
What is the current status of trial NCT00356512?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2006-07-19.
Who is sponsoring clinical trial NCT00356512?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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