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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Vascular Disease Cognitive Decline Hearing Loss Inflammation Age-Related Memory Disorder Behavioral: folic acid (0.8 mg) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 835 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial
Study Start Date : September 2000
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in mean carotid intima-media thickness
  2. Change in maximum carotid intima-media thickness

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110604

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Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
Wageningen University
Wageningen Centre for Food Sciences
ZonMw: The Netherlands Organisation for Health Research and Development
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Principal Investigator: Petra Verhoef, PhD Wageningen Centre for Food Sciences
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00110604    
Other Study ID Numbers: Pou.0224L
ZonMw 20010002
First Posted: May 11, 2005    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: May 2005
Keywords provided by Wageningen University:
Folic acid
Cognitive function
Arterial stiffness
Additional relevant MeSH terms:
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Hearing Loss
Memory Disorders
Vascular Diseases
Cognitive Dysfunction
Pathologic Processes
Arterial Occlusive Diseases
Cardiovascular Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Folic Acid
Vitamin B Complex
Physiological Effects of Drugs