Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals

Sponsor

National Center for Research Resources (NCRR) (NIH)

Overall Status

Completed

CT.gov ID

NCT00018135

Collaborator

(none)

Location

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Renal Failure	Drug: calcium acetate Drug: aluminum hydroxide Drug: Sevelamer	N/A

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 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Primary Purpose:

Prevention

Official Title:

Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	St. Louis	Missouri	United States	63110

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00018135

Other Study ID Numbers:

NCRR-M01RR00036-0795

First Posted:

Jul 5, 2001

Last Update Posted:

Jun 24, 2005

Last Verified:

Dec 1, 2003

Keywords provided by , ,

high iPTH levels

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2005