Trial of Folic Acid Effect on Hcy and cIMT After Kidney Tx - Full Text View

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00570856

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 IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Folic acid Homocysteine

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation

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 ]

Arms	Assigned Interventions
1: Experimental Folic acid supplementation	Drug: Folic acid Folic acid 5 mg/day
2: Placebo Comparator	Drug: Placebo Placebo similar to the folic acid tablets, 1/day

Eligibility

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:

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

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

Keywords provided by Shaheed Beheshti Medical University:

Folic Acid
Homocysteine
intima-media thickness

Study placed in the following topic categories:

Folic Acid

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009