NCT00570856

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
Last Updated

December 19, 2007

Status Verified

December 1, 2007

First QC Date

December 10, 2007

Last Update Submit

December 14, 2007

Conditions

Kidney Transplantation

Keywords

Folic AcidHomocysteineintima-media thickness

Outcome Measures

Primary Outcomes (1)

  • plasma level of total homocysteine (tHcy)

    6 months

Secondary Outcomes (1)

  • carotid intima-media thickness (cIMT)

    6 months

Study Arms (2)

1

EXPERIMENTAL

Folic acid supplementation

Drug: Folic acid

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Folic acidDRUG

Folic acid 5 mg/day

1
PlaceboDRUG

Placebo similar to the folic acid tablets, 1/day

2

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mohsen Nafar, MD- Nephrologist

    Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 11, 2007

Study Start

June 1, 2005

Study Completion

March 1, 2006

Last Updated

December 19, 2007

Record last verified: 2007-12