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

Sponsor

Wageningen University (Other)

Overall Status

Completed

CT.gov ID

NCT00110604

Collaborator

Wageningen Centre for Food Sciences (Other), ZonMw: The Netherlands Organisation for Health Research and Development (Other)

835

Enrollment

Location

Duration (Months)

16.4

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2000

Study Completion Date :

Dec 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

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