Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00018135
First received: July 3, 2001
Last updated: June 23, 2005
Last verified: December 2003

July 3, 2001
June 23, 2005
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Complete list of historical versions of study NCT00018135 on ClinicalTrials.gov Archive Site
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Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals
Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals

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

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 200pg/ml and a serum phosphorus level of at least 4.0 mg/dl.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Renal Failure
  • Drug: calcium acetate
  • Drug: aluminum hydroxide
  • Drug: Sevelamer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion criteria:

  • Patients 18 years of age or older
  • Receiving treatment with hemodialysis for at least 90 days
  • Serum iPTH levels greater than 200pg/ml
  • Serum phosphorus levels greater than 4.0mg/dl
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00018135
NCRR-M01RR00036-0795
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National Center for Research Resources (NCRR)
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National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP