Trial of Folic Acid Effect on Hcy and cIMT After Kidney Tx

Phase 4

Terminated

• Conditions: Kidney Transplantation
• Interventions: Drug: Folic acid; Drug: Placebo

• Registration Number: NCT00570856
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study Completion: 2006-03
• Status Verified: 2007-12
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Last Update Submitted: 2007-12-14
• Last Update Posted: 2007-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• having hyperhomocysteinemia(tHcy>12.5 µmol/L in men and 11.5 µmol/L in women )
• No evident history of CVD 4. no evidence of cigarette smoking
• not participating in other clinical studies on evaluation of cardiac diseases and
• not taking any lipid lowering treatment
• not being pregnant or breast feeding a baby(women)
• Having HIV or viral hepatitis infections.

Exclusion Criteria

• unstable condition of the transplanted kidney (Cr> 3 mg/dl, BUN > 50 mg/dl)
• Cyclosporine (CsA) intoxication
• New onset of any severe disease ( such as MI, stroke, DM, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Folic acid	Folic acid supplementation
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
plasma level of total homocysteine (tHcy)	6 months

Secondary Outcome Measures

Name	Time	Method
carotid intima-media thickness (cIMT)	6 months