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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00570856
First Posted: December 11, 2007
Last Update Posted: December 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness

Condition Intervention Phase
Kidney Transplantation Drug: Folic acid Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • plasma level of total homocysteine (tHcy) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • carotid intima-media thickness (cIMT) [ Time Frame: 6 months ]

Enrollment: 60
Study Start Date: June 2005
Study Completion Date: March 2006
Arms Assigned Interventions
Experimental: 1
Folic acid supplementation
Drug: Folic acid
Folic acid 5 mg/day
Placebo Comparator: 2 Drug: Placebo
Placebo similar to the folic acid tablets, 1/day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570856


Sponsors and Collaborators
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
  More Information

Responsible Party: Dr. Mohsen Nafar, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00570856     History of Changes
Other Study ID Numbers: 110
First Submitted: December 10, 2007
First Posted: December 11, 2007
Last Update Posted: December 19, 2007
Last Verified: December 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
Folic Acid
Homocysteine
intima-media thickness

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs


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