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document
Rationale and design of the Folic Acid for Vascular Outcome Reduction In Transplantation ( FAVORIT ) trial . BACKGROUND Patients with chronic kidney disease , including kidney transplant recipients , are at high risk for cardiovascular disease ( CVD ) . In addition to the constellation of traditional CVD risk factors in chronic kidney disease , elevated total homocysteine ( tHcy ) is notably more prevalent among the general population . The Folic Acid for Vascular Outcome Reduction In Transplantation ( FAVORIT ) trial is designed to evaluate whether lowering tHcy using vitamin supplementation reduces CVD events in renal transplant recipients . METHODS FAVORIT is a multicenter double-blind randomized controlled clinical trial . Participants are clinically stable renal transplant recipients who are 6 months or longer posttransplant with elevated tHcy . Patients are randomized to a multivitamin that includes either a high-dose or low-dose of folic acid ( 5 or 0 mg ) , vitamin B6 ( 50 or 1.4 mg ) , and vitamin B12 ( 1000 or 2 microg ) . The primary end point is a composite of incident or recurrent CVD outcomes , that is , coronary heart , cerebrovascular , or abdominal aortic/lower extremity arterial events . A sample size of 4000 is estimated to provide 87 % power to detect a 20 % treatment effect . Recruitment is expected to continue until July 2006 , with follow-up through June 2010 . RESULTS From August 2002 through December 2004 , 2234 of the target 4000 patients were enrolled . In accordance with trial design , mean ( SD ) screening tHcy was elevated ( 17.4 +/- 6.2 micromol/L ) , and mean ( SD ) estimated creatinine clearance was consistent with stable renal function ( 58.0 +/- 18.6 mL/min ) . Evaluating baseline results to date , 42 % of the randomized participants had a history of diabetes mellitus , and 21 % had prevalent CVD . CONCLUSIONS The FAVORIT trial is designed with sufficient power and follow-up time to detect a clinically relevant change in CVD risk between renal transplant recipients receiving a high or low tHcy-lowering folic acid multivitamin . Preliminary screening and baseline data support the trial 's objectives .
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Intervention_Pharmacological
Folic Acid
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Intervention_Pharmacological
The Folic Acid
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Intervention_Pharmacological
vitamin supplementation
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Intervention_Pharmacological
multivitamin that includes either a high-dose or low-dose of folic acid
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Intervention_Pharmacological
vitamin B6
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Intervention_Pharmacological
and vitamin B12
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Intervention_Pharmacological
folic acid multivitamin
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Outcome_Physical
cardiovascular disease ( CVD )
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Outcome_Physical
total homocysteine ( tHcy )
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Outcome_Physical
CVD events
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Outcome_Physical
composite of incident or recurrent CVD outcomes , that is , coronary heart , cerebrovascular , or abdominal aortic/lower extremity arterial events
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Outcome_Physical
mean ( SD ) screening tHcy
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Outcome_Physical
mean ( SD ) estimated creatinine clearance
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Outcome_Physical
history of diabetes mellitus
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Participant_Condition
chronic kidney disease
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Participant_Condition
kidney transplant recipients
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Participant_Condition
renal transplant recipients
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Participant_Condition
renal transplant recipients
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Participant_Condition
elevated tHcy
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Participant_Sample-size
2234
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Participant_Sample-size
4000
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Participant_Condition
renal transplant recipients