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

Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00570856

Enrollment

Registered

2007-12-11

Start date

2005-06-30

Completion date

2006-03-31

Last updated

2007-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Folic Acid, Homocysteine, intima-media thickness

Brief summary

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

Interventions

DRUGFolic acid

Folic acid 5 mg/day

DRUGPlacebo

Placebo similar to the folic acid tablets, 1/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

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.).

Design outcomes

Primary

Measure	Time frame
plasma level of total homocysteine (tHcy)	6 months

Secondary

Measure	Time frame
carotid intima-media thickness (cIMT)	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026