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

December 14, 2007 updated by: Shahid Beheshti University of Medical Sciences

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Placebo similar to the folic acid tablets, 1/day
Experimental: 1
Folic acid supplementation
Drug: Folic acid
Folic acid 5 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma level of total homocysteine (tHcy)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
carotid intima-media thickness (cIMT)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Chair: Mohsen Nafar, MD- Nephrologist, Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
  • Principal Investigator: Farideh Khatami, Master of Science, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
  • Principal Investigator: Babak Kardavani, M.D., Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2007

Last Update Submitted That Met QC Criteria

December 14, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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