Clinical trialNCT00032435CompletedPhase 3Interventional

Homocysteine Study (HOST)

SponsorUS Department of Veterans AffairsEnrollment2,003End Stage Renal DiseaseRenal Failure

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Rex L. Jamison
VA Palo Alto Health Care System
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

37 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Va Medical Center, San Juan
San Juan, Puerto Rico

United States

Va Medical Center, Birmingham
Birmingham, Alabama, United States
Health Economics Resource Center (herc), Menlo Park
Menlo Park, California, United States
Va Palo Alto Health Care System
Palo Alto, California, United States
Va San Diego Healthcare System, San Diego
San Diego, California, United States
Va Eastern Colorado Health Care System, Denver
Denver, Colorado, United States
Va Connecticut Health Care System (west Haven)
West Haven, Connecticut, United States
Va Medical Center, Dc
Washington D.C., District of Columbia, United States
Va Medical Center, Bay Pines
Bay Pines, Florida, United States
North Florida/south Georgia Veterans Health System
Gainesville, Florida, United States
Va Medical Center, Miami
Miami, Florida, United States
West Palm Beach Va Medical Center
West Palm Beach, Florida, United States
Edward Hines, Jr. Va Hospital
Hines, Illinois, United States
Richard Roudebush Va Medical Center, Indianapolis
Indianapolis, Indiana, United States
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States
Va Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States
Va Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
John D. Dingell Va Medical Center, Detroit
Detroit, Michigan, United States
Va Medical Center, Minneapolis
Minneapolis, Minnesota, United States
G.V. (sonny) Montgomery Va Medical Center, Jackson
Jackson, Mississippi, United States
Va Medical Center, Kansas City Mo
Kansas City, Missouri, United States
Va Western New York Healthcare System at Buffalo
Buffalo, New York, United States
New York Harbor Hcs
New York, New York, United States
Va Medical Center, Northport
Northport, New York, United States
Va Medical Center, Syracuse
Syracuse, New York, United States
Va Medical Center, Bronx
The Bronx, New York, United States
Va Medical Center, Cleveland
Cleveland, Ohio, United States
Va Medical Center, Dayton
Dayton, Ohio, United States
Va Medical Center, Portland
Portland, Oregon, United States
Va Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States
Ralph H Johnson Va Medical Center, Charleston
Charleston, South Carolina, United States
Va Medical Center, Memphis
Memphis, Tennessee, United States
Va North Texas Health Care System, Dallas
Dallas, Texas, United States
Michael E. Debakey Va Medical Center (152)
Houston, Texas, United States
Hunter Holmes Mcguire Va Medical Center
Richmond, Virginia, United States
Va Puget Sound Health Care System, Seattle
Seattle, Washington, United States
Zablocki Va Medical Center, Milwaukee
Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PAL-40 ActivePAL-40 Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2001
Primary completion: 31 Aug 2006
Completion: 30 Sept 2006
Last update posted: 15 Oct 2010
Registered enrollment: 2,003
Registry id: NCT00032435

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.