Inflammation Clinical Trial
Official title:
The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial
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.
Status | Completed |
Enrollment | 835 |
Est. completion date | December 2004 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | Wageningen Centre for Food Sciences, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
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 |
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