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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110604
• Other study ID #: Pou.0224L
• Secondary ID: ZonMw 20010002
• Status: Completed
• Phase: N/A
• First received: May 10, 2005
• Last updated: December 29, 2008
• Start date: September 2000
• Est. completion date: December 2004

Study information

• Verified date: May 2005
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-Related Memory Disorder
• Atherosclerosis
• Cognitive Decline
• Hearing Loss
• Inflammation
• Memory Disorders
• Vascular Disease
• Vascular Diseases

Intervention

Behavioral:
• folic acid (0.8 mg)

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Wageningen Centre for Food Sciences, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean carotid intima-media thickness
Primary	Change in maximum carotid intima-media thickness
Secondary	Change in carotid distension
Secondary	Change in hearing levels (pure tone air conduction averages of 0.5, 1, and 2 kHz & 4, 6 and 8 kHz)
Secondary	Cognitive performance at year 3 (cognitive domains: simple speed, cognitive flexibility, and memory; and information processing speed and semantic memory)
Secondary	Inflammatory markers and hemostasis markers

External Links

•   FACIT study website