Isoflavones and Acute-phase Response in Chronic Renal Failure

NCT00029796 | Completed Phase 2

• 1 other identifier: R21AT000205-01A1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Failure, Chronic

Interventions

soy isoflavones DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2002
• First Posted: January 24, 2002
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

US (1)