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Parathyroid hormone levels in relation to the phosphorus content of meals Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Parathyroid hormone levels in relation to the phosphorus content of meals conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Parathyroid hormone levels in relation to the phosphorus content of meals Clinical research trials and Parathyroid hormone levels in relation to the phosphorus content of meals medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Parathyroid hormone levels in relation to the phosphorus content of meals. Parathyroid hormone levels in relation to the phosphorus content of meals Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Parathyroid hormone levels in relation to the phosphorus content of meals clinical trial. Participants oftentimes recieve the finest healthcare available for their Parathyroid hormone levels in relation to the phosphorus content of meals condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Parathyroid hormone levels in relation to the phosphorus content of meals  Parathyroid hormone levels in relation to the phosphorus content of meals
Parathyroid hormone levels in relation to the phosphorus content of meals
For Condition: Renal Failure
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: 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
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: 1. Patients 18 years of age or older 2. Receiving treatment with hemodialysis for at least 90 days 3. Serum iPTH levels greater than 200pg/ml 4. Serum phosphorus levels greater than 4.0mg/dl
Total Enrollment:
Location and Contact Information:
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00036-0795;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00018135
Other Renal Failure Studies:
1. Homocysteine Study (HOST)
2. Parathyroid hormone levels in relation to the phosphorus content of meals
Related Studies:
Other Renal Failure Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Parathyroid hormone levels in relation to the phosphorus content of meals
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