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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:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00570856
First received: December 10, 2007
Last updated: December 14, 2007
Last verified: December 2007
  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:


Further study details as provided by Shahid 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570856

Sponsors and Collaborators
Shahid 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 Shahid Beheshti Medical University:
Folic Acid
Homocysteine
intima-media thickness

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

ClinicalTrials.gov processed this record on November 27, 2014