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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110604
Recruitment Status : Completed
First Posted : May 11, 2005
Last Update Posted : December 31, 2008
Wageningen Centre for Food Sciences
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Wageningen University

May 10, 2005
May 11, 2005
December 31, 2008
September 2000
Not Provided
  • Change in mean carotid intima-media thickness
  • Change in maximum carotid intima-media thickness
Same as current
Complete list of historical versions of study NCT00110604 on Archive Site
  • 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
Same as current
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The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Atherosclerosis
  • Vascular Disease
  • Cognitive Decline
  • Hearing Loss
  • Inflammation
  • Age-Related Memory Disorder
Behavioral: folic acid (0.8 mg)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2004
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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
Sexes Eligible for Study: All
50 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
ZonMw 20010002
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Wageningen University
  • Wageningen Centre for Food Sciences
  • ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Petra Verhoef, PhD Wageningen Centre for Food Sciences
Wageningen University
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP