The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing

December 29, 2008 updated by: Wageningen University

The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial

The purpose of this study is to determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low levels of B vitamins, in particular folate, and high levels of plasma total homocysteine, have been associated with a variety of age-related diseases and disorders, including cardiovascular disease, dementia and hearing impairment. Extra folate, for example in the form of folic acid, is known to decrease the concentrations of plasma total homocysteine.

We examined whether 0.8 mg/d folic acid could slow down atherosclerotic progression and the above mentioned age-related processes.

Study Type

Interventional

Enrollment

835

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6700 EV
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 50-70 years
  • Men and post-menopausal women
  • Women with a surgically removed uterus were required to be >=55 years

Exclusion Criteria:

  • Plasma total homocysteine <13 or >26 umol/L
  • Serum vitamin B12 <200 pmol/L
  • Self-reported current use of drugs which affect folate metabolism
  • Self-reported current use of drugs believed to influence intima-media thickening, i.e., lipid-lowering drugs, hormone replacement therapy
  • Self-reported medical diagnosis of renal, intestinal, thyroid disease
  • Self-reported medical diagnosis of current cancer
  • Self-reported current use of supplements containing B vitamins
  • Self-reported inability or unwillingness to fast for 12 hours
  • <80% compliance using placebo pills during a 6-week run-in period
  • Not giving written informed consent
  • Participation in other research studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in mean carotid intima-media thickness
Change in maximum carotid intima-media thickness

Secondary Outcome Measures

Outcome Measure
Change in carotid distension
Change in hearing levels (pure tone air conduction averages of 0.5, 1, and 2 kHz & 4, 6 and 8 kHz)
Cognitive performance at year 3 (cognitive domains: simple speed, cognitive flexibility, and memory; and information processing speed and semantic memory)
Inflammatory markers and hemostasis markers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Wageningen Centre for Food Sciences

Investigators

  • Principal Investigator: Petra Verhoef, PhD, Wageningen Centre for Food Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

May 10, 2005

First Submitted That Met QC Criteria

May 10, 2005

First Posted (Estimate)

May 11, 2005

Study Record Updates

Last Update Posted (Estimate)

December 31, 2008

Last Update Submitted That Met QC Criteria

December 29, 2008

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pou.0224L
  • ZonMw 20010002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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