Homocysteine Study (HOST)

Completed · Phase 3 · Has a placebo group

Conditions studied: End Stage Renal Disease, Renal Failure

In brief

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.

Key facts

Study ID

NCT00032435

Run by

US Department of Veterans Affairs

People needed

2003

Starts

2001-05-01

Expected to finish

2006-09-01

Last updated by the study team

2010-10-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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