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

Shahid Beheshti University of Medical Sciences

Status and phase: Terminated; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Folic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00570856

110

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Folic acid supplementation

Treatment:

Drug: Folic acid

2

Placebo Comparator group

Treatment:

Drug: Placebo