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

This study has been completed.
Sponsor:
Collaborators:
Wageningen Centre for Food Sciences
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00110604
First received: May 10, 2005
Last updated: December 29, 2008
Last verified: May 2005

May 10, 2005
December 29, 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Atherosclerosis
  • Vascular Disease
  • Cognitive Decline
  • Hearing Loss
  • Inflammation
  • Age-Related Memory Disorder
Behavioral: folic acid (0.8 mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
835
December 2004
Not Provided

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
Both
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00110604
Pou.0224L, ZonMw 20010002
Not Provided
Not Provided
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