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

Not Applicable

Completed

• Conditions: Atherosclerosis; Vascular Disease; Cognitive Decline; Hearing Loss; Inflammation; Age-Related Memory Disorder

• Registration Number: NCT00110604
• Lead Sponsor: Wageningen University

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.

Study Timeline

• Study Start: 2000-09
• Study Completion: 2004-12
• Status Verified: 2005-05
• Study First Submitted: 2005-05-10
• Study First Submitted QC: 2005-05-10
• Study First Posted: 2005-05-11
• Last Update Submitted: 2008-12-29
• Last Update Posted: 2008-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 835

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in mean carotid intima-media thickness
Change in maximum carotid intima-media thickness

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Gelderland, Netherlands