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

NCT ID: NCT00570856

Last Updated: 2007-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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Conditions

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Kidney Transplantation

Keywords

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Folic Acid Homocysteine intima-media thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Folic acid supplementation

Group Type EXPERIMENTAL

Folic acid

Intervention Type DRUG

Folic acid 5 mg/day

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo similar to the folic acid tablets, 1/day

Interventions

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Folic acid

Folic acid 5 mg/day

Intervention Type DRUG

Placebo

Placebo similar to the folic acid tablets, 1/day

Intervention Type DRUG

Eligibility Criteria

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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.).
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shaheed Beheshti Medical University

Principal Investigators

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Mohsen Nafar, MD- Nephrologist

Role: STUDY_CHAIR

Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Farideh Khatami, Master of Science

Role: PRINCIPAL_INVESTIGATOR

Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Babak Kardavani, M.D.

Role: PRINCIPAL_INVESTIGATOR

Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Other Identifiers

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110

Identifier Type: -

Identifier Source: secondary_id

110

Identifier Type: -

Identifier Source: org_study_id