Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018135
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-07-03
Brief Title:
Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals
Status:
COMPLETED
Status Verified Date:
2003-12
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:
Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the iPTH level This chronic elevation in iPTH can have adverse consequences thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet Some preliminary studies have indicated that the iPTH level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus If this is true in hemodialysis patients then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered
Detailed Description:
Drugs used will include three phosphate binders already approved and commonly used Calcium acetate aluminum hydroxide and sevelamer Renagel will be given on separate occasions in conjunction with a high phosphorus meal They will be given in standard doses used in the treatment of high phosphorus levels in hemodialysis patients
The population targeted will included hemodialysis patients with elevated iPTH and phosphorus levels
The patients will receive up to five separate meals Four of these will be high phosphorus content meals and one will be a low phosphorus content meal On up to three occasions with the high phosphorus content meals the patients will ingest one of the three phosphate binders The meals will be ingested after a twelve-hour overnight fast Labs will be drawn prior to meal ingestion and then at 15 30 60 120 and 240-minute intervals The labs will consist of iPTH phosphorus calcium and glucose A serum albumin level will be obtained with the initial specimen only The patients will have an iPTH level of at least 200pgml and a serum phosphorus level of at least 40 mgdl
The primary outcome will be the change in the iPTH level in relation to the phosphorus content of the meals Secondary outcomes will include the change in iPTH level in relation to the various phosphate binders being used
The population targeted will included hemodialysis patients with elevated iPTH and phosphorus levels
The patients will receive up to five separate meals Four of these will be high phosphorus content meals and one will be a low phosphorus content meal On up to three occasions with the high phosphorus content meals the patients will ingest one of the three phosphate binders The meals will be ingested after a twelve-hour overnight fast Labs will be drawn prior to meal ingestion and then at 15 30 60 120 and 240-minute intervals The labs will consist of iPTH phosphorus calcium and glucose A serum albumin level will be obtained with the initial specimen only The patients will have an iPTH level of at least 200pgml and a serum phosphorus level of at least 40 mgdl
The primary outcome will be the change in the iPTH level in relation to the phosphorus content of the meals Secondary outcomes will include the change in iPTH level in relation to the various phosphate binders being used
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: