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

This study has been terminated.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00570856
First received: December 10, 2007
Last updated: December 14, 2007
Last verified: December 2007
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • plasma level of total homocysteine (tHcy) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • carotid intima-media thickness (cIMT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570856

Sponsors and Collaborators
Shaheed Beheshti Medical University
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

No publications provided

Responsible Party: Dr. Mohsen Nafar, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00570856     History of Changes
Other Study ID Numbers: 110, 110
Study First Received: December 10, 2007
Last Updated: December 14, 2007
Health Authority: Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:
Folic Acid
Homocysteine
intima-media thickness

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013