Isoflavones and Acute-phase Response in Chronic Renal Failure

Completed · Phase 2

Conditions studied: Kidney Failure, Chronic

In brief

This is a randomized, double-blinded dietary intervention in hemodialysis patients to determine the clinical and metabolic effects of soy isoflavones on disease activity, including improvement of blood markers of acute-phase response, and decreased blood levels of markers of metabolic bone disease.

Key facts

Study ID

NCT00029796

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

52

Expected to finish

2003-09-01

Last updated by the study team

2013-03-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Initiation of chronic hemodialysis therapy more than 6 months prior to enrollment in the study.
• Routine dialysis with highly biocompatible dialysis membranes, including polysulfone, polycarbonate, polyamide, or polymethylmethacrylate membranes.
• Historical compliance with three times weekly routine hemodialysis therapy.
• Ability and willingness to adhere to the intake of soy protein isolate drinks during dialysis therapy.

You may not qualify if…

• Use of calcitriol within the last six weeks
• Acute illness known to cause acute-phase response, including clinically detectable infections, trauma, surgery, burns, and tissue infarction, within the last 6 weeks.
• Chronic conditions known to cause acute-phase response, including immunologically-mediated and crystal-induced illnesses, cancer, and psychiatric illnesses.
• Hematocrit below 30%
• Aluminum intoxication
• Smoking
• Gastrointestinal disturbances that can interfere with isoflavone absorption, including acute gastrointestinal illness and/or intestinal microflora depletion following use of antibiotics within the last three months, chronic malabsorption syndrome, chronic liver disease.
• Other significant medical illnesses including decompensated heart failure, unstable coronary artery disease, advanced chronic obstructive pulmonary disease, decompensated thyroid disease, alcoholism, substance abuse.

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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