Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals

June 23, 2005 updated by: National Center for Research Resources (NCRR)
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 3, 2001

First Submitted That Met QC Criteria

July 4, 2001

First Posted (Estimate)

July 5, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00036-0795

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Failure

Clinical Trials on Sevelamer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe