NCT00217100

Brief Summary

This study is being done to compare arteriosclerotic cardiovascular disease in kidney transplant recipient taking a standard multivitamin versus those taking a multivitamin augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

Enrollment Period

5.3 years

First QC Date

September 20, 2005

Last Update Submit

April 23, 2012

Conditions

Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (1)

  • Estimated Average Requirement (EAR) amounts

    to determine whether total homocysteine (tHcy)-lowering treatment with a standard multivitamin augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6, versus treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement (EAR) amounts of vitamin B6 and vitamin B12., reduces the pooled rate of recurrent and de novo cardiovascular disease \[CVD\]outcomes

    basline to death or common end date 4.5 years

Study Arms (2)

Multi Vitamin Formulation

ACTIVE COMPARATOR
Dietary Supplement: Multivitamin

Sugar pill

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

MultivitaminDIETARY_SUPPLEMENT

1 tablet a day

Multi Vitamin Formulation
PlaceboDIETARY_SUPPLEMENT

1 tablet a day

Sugar pill

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Participants with elevated homocysteine levels that are between the ages of 35-75 years old and have had a kidney transplant with stable renal graft function.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Geritol

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

October 1, 2004

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 25, 2012

Record last verified: 2012-04

Locations

US(1)