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Homocysteine Study (HOST) Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Homocysteine Study (HOST) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Homocysteine Study (HOST) Clinical research trials and Homocysteine Study (HOST) healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Homocysteine Study (HOST). Homocysteine Study (HOST) Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Homocysteine Study (HOST) clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Homocysteine Study (HOST) condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > Homocysteine Study (HOST)  Homocysteine Study (HOST)
Homocysteine Study (HOST)
For Condition: Renal Failure,End Stage Renal Disease
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,Pan American Laboratories,Abbott Laboratories
Synopsis: The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.
Details: Primary Hypothesis: The primary objective of this proposal is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and increase survival. Secondary Hypotheses: The secondary objectives are to test the hypotheses that intake of the vitamins decreases: 1) MI, 2) stroke, 3) amputation of lower extremity, 4) combination death, MI, stroke and amputation of lower extremity, 5) thrombosis of the vascular access in hemodialysis patients. Primary Outcome: Death Interventions: A treated group that receives a daily tablet containing 40 mg of folic acid, 100 mg of pyridoxine and 2 mg of B12 versus a control group that receives a placebo. Study Abstract: For more than 20 years, an abundance of published reports has shown a strong correlation between homocysteinemia and the incidence of cardiovascular death and disease. Authors of these papers have unanimously recommended a study be undertaken to determine if folate, pyridoxine, and vitamin B12 can lower the incidence. This proposal is a response to that recommendation. The study is to be conducted in patients with chronic renal failure and end-stage renal disease whose plasma homocysteine levels and incidence of cardiovascular death and disease are among the highest of all patient populations. The experimental design is a prospective, two-arm, randomized, double blind study, stratified for medical center and whether the patient has chronic renal failure or end-stage renal disease. We will use stratified randomization to insure that the treatment is balanced within the end-stage renal disease patients and chronic renal failure patients. This 6-year study will require an accrual phase of 2 years and a treatment phase lasting a minimum of 4 years. Patients will be screened by their plasma homocysteine concentration. They must have a level of at least 15 µM/L to be enrolled in the study. Baseline demographic and medical information, laboratory data including plasma homocysteine and vitamin levels, will be obtained. Patients will be seen at the medical center at 3 months but thereafter will be contacted by phone and mail. The patients will receive the study drug by mail from Albuquerque. For a relative treatment effect of 17%, (that is reducing the 3 year death rate from 28% to 23%), and 80% power, 2006 patients and 36 VA medical centers are required. By screening for patients with high plasma homocysteine concentrations and measuring the levels after 3 months, we will be able to determine if the hypothesized reduction in death and cardiovascular event rate is associated with a decrease in plasma homocysteine concentration. The study kick-off was held July 24-26, 2001, and patient intake began 9/26/2001. Patient enrollment is almost completed with 99% of target enrolled.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: Patients will be screened by their plasma homocysteine concentration. They must have a level of at least 15 mM/L to be enrolled in the study. Patients will be excluded by any of the following criteria: age less than 21 years, expected life span less than 6 months, pregnancy, metastatic cancer, end-stage liver disease, treatment with methotrexate, other anti-folate medication or anticonvulsants, unreliable or likely noncompliant, participation in another long-term trial, or unwilling or unable to give informed consent.
Total Enrollment: 2006
Location and Contact Information:
Malcom Randall VAMC
Gainesville, Florida, 32608-1197
United States
Washington, DC VAMC
Washington D.C., District of Columbia, 20422
United States
VACT Healthcare System
West Haven, Connecticut, 06516
United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
United States
Minneapolis VAMC
Minneapolis, Minnesota, 55417
United States
Memphis VAMC
Memphis, Tennessee, 38104
United States
Northport VAMC
Northport, New York, 11768-2290
United States
Bay Pines VAMC
Bay Pines, Florida, 33744
United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108-1597
United States
VA Healthcare Network Upstate NY @ Syracuse
Syracuse, New York, 13210
United States
Houston VAMC
Houston, Texas, 77030-4298
United States
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401-5799
United States
Miami VAMC
Miami, Florida, 33125
United States
VA Western NY Healthcare System
Buffalo, New York, 14215
United States
Birmingham VAMC
Birmingham, Alabama, 35233
United States
Richard L. Roudebush VAMC
Indianapolis, Indiana, 46202
United States
VA Boston Healthcare System
Boston, Massachusetts, 02130
United States
VA New York Harbor Healthcare System
New York City, New York, 10010
United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
United States
Kansas City VAMC
Kansas City, Missouri, 64128
United States
Portland VAMC
Portland, Oregon, 97207
United States
San Juan VAMC
San Juan, , 00921-3201
Puerto Rico
G.V. (Sonny) Montgomery VAMC
Jackson, Mississippi, 39216
United States
Hunter Holmes McGuire VAMC
Richmond, Virginia, 23249
United States
Clement J. Zablocki VAMC
Milwaukee, Wisconsin, 53295
United States
VA San Diego Healthcare System
San Diego, California, 92161
United States
VA North Texas Healthcare System
Dallas, Texas, 75216
United States
Dayton VAMC
Dayton, Ohio, 45428
United States
VA Palo Alto Healthcare System
Palo Alto, California, 94304
United States
Bronx VAMC
Bronx, New York, 10468
United States
West Palm Beach VAMC
West Palm Beach, Florida, 33410-6400
United States
John D. Dingell VAMC
Detroit, Michigan, 48201-1932
United States
New Orleans VAMC
New Orleans, Louisiana, 70146
United States
Louis Stokes Cleveland VAMC
Cleveland, Ohio, 44106
United States
Denver VAMC
Denver, Colorado, 80220
United States
Additional Information:
Study ID Numbers: 453;
Study Start Date: May 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032435
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 California Clinical Trials
Other Palo Alto Clinical Trials
Homocysteine Study (HOST)
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