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NCT00570856 Clinical Trial

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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00570856
Other study ID # 110
Secondary ID 110
Status Terminated
Phase Phase 4
First received December 10, 2007
Last updated December 14, 2007
Start date June 2005
Est. completion date March 2006

Study information
Verified date December 2007
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 65 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Folic acid
Folic acid 5 mg/day
• Placebo
Placebo similar to the folic acid tablets, 1/day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary plasma level of total homocysteine (tHcy) 6 months No
Secondary carotid intima-media thickness (cIMT) 6 months No
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