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Completed

NCT Number: NCT00110604

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

folic acid (0.8 mg)

Behavioral

Primary outcomes

  1. Change in mean carotid intima-media thickness

  2. Change in maximum carotid intima-media thickness

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2004
First posted
May 11, 2005
Registry last updated
Dec 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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