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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Atherosclerosis, Vascular Disease, Cognitive Decline, Hearing Loss, Inflammation, Age-Related Memory Disorder

Intervention / Treatment
-----------------
* Behavioral: folic acid (0.8 mg)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: folic acid (0.8 mg)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean carotid intima-media thickness |  |  | 
| Change in maximum carotid intima-media thickness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, Folic acid, Atherosclerosis, Cognitive function, Hearing, Hemostasis, Arterial stiffness