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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
  Purpose

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 Intervention
Atherosclerosis
Vascular Disease
Cognitive Decline
Hearing Loss
Inflammation
Age-Related Memory Disorder
Behavioral: folic acid (0.8 mg)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Change in mean carotid intima-media thickness
  • Change in maximum carotid intima-media thickness

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 835
Study Start Date: September 2000
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110604

Locations
Netherlands
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
Investigators
Principal Investigator: Petra Verhoef, PhD Wageningen Centre for Food Sciences
  More Information

Additional Information:
No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00110604     History of Changes
Other Study ID Numbers: Pou.0224L, ZonMw 20010002
Study First Received: May 10, 2005
Last Updated: December 29, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:
Folic acid
Atherosclerosis
Cognitive function
Hearing
Inflammation
Hemostasis
Arterial stiffness

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Deafness
Hearing Loss
Inflammation
Memory Disorders
Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Otorhinolaryngologic Diseases
Pathologic Processes
Sensation Disorders
Signs and Symptoms
Folic Acid
Vitamin B Complex
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014