Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032435
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2002-03-20
Brief Title:
Homocysteine Study HOST
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 453 - Homocysteinemia in Kidney and Endstage Renal Disease Study HOST
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 40mg of folic acid 100mg of pyridoxine and 2mg of B12 versus a control group that receives a placebo
Study Abstract
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 In each arm 1003 patients will ingest daily a capsule containing either 40mg of folic acid 100mg of pyridoxine and 2mg of vitamin B12 or placebo We will use stratified randomization to ensure 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 uML to be enrolled in the study The study nurse will evaluate each patient at 3 months Thereafter patients will be contacted by phone or mail if they prefer at 3-month intervals by coordinators at a central location Secondary endpoint events hospitalization onset of dialysis and death or other reason for exit from the study will be recorded on standard forms Plasma homocysteine levels will be obtained at 3 months in all patients
Patients will be excluded if age less than 21 years expected life span less than 6 months pregnancy metastatic cancer AIDS-related infection end-stage liver disease vitamin B12 deficiency treatment with methotrexate or anticonvulsants unreliable or likely non-compliant participation in other long-term trial or unwilling or unable to give informed consent
For a relative treatment effect of 17 that is reducing the 3-year death rate from 28 to 232 and 80 power 2006 patients and 36 VA medical centers are required
An abundance of published reports has shown a strong correlation between homocysteinemia and the incidence of cardiovascular death Authors of these papers have unanimously recommended a study be undertaken to determine if folate pyridoxine and vitamin B12 can lower the incidence
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 By screening for patients with high plasma homocysteine concentrations and measuring the levels after 3 months we will be able to determine if the hypothetical reduction in death and cardiovascular event rate is associated with a decrease in plasma homocysteine concentration
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 40mg of folic acid 100mg of pyridoxine and 2mg of B12 versus a control group that receives a placebo
Study Abstract
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 In each arm 1003 patients will ingest daily a capsule containing either 40mg of folic acid 100mg of pyridoxine and 2mg of vitamin B12 or placebo We will use stratified randomization to ensure 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 uML to be enrolled in the study The study nurse will evaluate each patient at 3 months Thereafter patients will be contacted by phone or mail if they prefer at 3-month intervals by coordinators at a central location Secondary endpoint events hospitalization onset of dialysis and death or other reason for exit from the study will be recorded on standard forms Plasma homocysteine levels will be obtained at 3 months in all patients
Patients will be excluded if age less than 21 years expected life span less than 6 months pregnancy metastatic cancer AIDS-related infection end-stage liver disease vitamin B12 deficiency treatment with methotrexate or anticonvulsants unreliable or likely non-compliant participation in other long-term trial or unwilling or unable to give informed consent
For a relative treatment effect of 17 that is reducing the 3-year death rate from 28 to 232 and 80 power 2006 patients and 36 VA medical centers are required
An abundance of published reports has shown a strong correlation between homocysteinemia and the incidence of cardiovascular death Authors of these papers have unanimously recommended a study be undertaken to determine if folate pyridoxine and vitamin B12 can lower the incidence
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 By screening for patients with high plasma homocysteine concentrations and measuring the levels after 3 months we will be able to determine if the hypothetical reduction in death and cardiovascular event rate is associated with a decrease in plasma homocysteine concentration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None