Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066183
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-08-04
Brief Title:
Studying Phosphorus Metabolism
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies in Phosphorus Metabolism
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phosphorus and phosphate irons play critical roles in bone structure and essential cellular functions
The purpose of this study is to learn more about the factors and hormones that regulate phosphorus in the body by collecting blood and urine samples from patients with disorders of phosphate control
Both children and adults will be enrolled in this study Researchers will collect blood and urine samples from participants on multiple occasions 2 to 6 times Some blood specimens will be taken after an overnight fast and participants may be asked to collect all their urine during a 24-hour period Researchers will analyze these blood and urine samples to better understanding how the body handles phosphorus
The purpose of this study is to learn more about the factors and hormones that regulate phosphorus in the body by collecting blood and urine samples from patients with disorders of phosphate control
Both children and adults will be enrolled in this study Researchers will collect blood and urine samples from participants on multiple occasions 2 to 6 times Some blood specimens will be taken after an overnight fast and participants may be asked to collect all their urine during a 24-hour period Researchers will analyze these blood and urine samples to better understanding how the body handles phosphorus
Detailed Description:
Phosphorus and phosphate ions play an important role in cellular metabolism as well as bone structure Scientific evidence suggests that in addition to Vitamin D and PTH systems novel factors such as Fibroblast Growth Factor 23 FGF-23 and Matrix extracellular phosphoglycoprotein MEPE may play an important role in phosphorus regulation These factors have been best studied in rare genetic and acquired phosphate wasting disorders such as tumor induced osteomalacia TIO X linked hypophosphatemia XLH and autosomal dominant hypophosphatemic rickets ADHR Patients with other abnormal phosphate regulating states such as hyperparathyroidism and hypoparathyroidism pseudohypoparathyroidism etc undergoing phosphorus-altering interventions may provide important insight into the role of these hormones
We are proposing an observational study with collection of blood and urine samples to study both established eg mineral ions bone markers PTH-Vit D system TMP-GFR and novel eg FGF-23 and MEPE constituents of the phosphorus metabolism pathway Patients with abnormal phosphorus regulating states will be enrolled and we will study the natural history of their disease and the effects of specific interventions that are likely to change phosphorus balance
The outcome will potentially aid understanding of this new field of mineral regulating hormones and generate both interest and research in phosphorus metabolism It is hoped that this will also encourage clinical trials in treatment of phosphate wasting disorders
We are proposing an observational study with collection of blood and urine samples to study both established eg mineral ions bone markers PTH-Vit D system TMP-GFR and novel eg FGF-23 and MEPE constituents of the phosphorus metabolism pathway Patients with abnormal phosphorus regulating states will be enrolled and we will study the natural history of their disease and the effects of specific interventions that are likely to change phosphorus balance
The outcome will potentially aid understanding of this new field of mineral regulating hormones and generate both interest and research in phosphorus metabolism It is hoped that this will also encourage clinical trials in treatment of phosphate wasting disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-D-0254 | None | None | None |