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	Treatment or Intervention
Atherosclerosis Vascular Disease Cognitive decline Hearing Loss Inflammation Age-Related Memory Disorder	Behavior: folic acid (0.8 mg)

Further Study Details: 

Primary Outcomes: Change in mean carotid intima-media thickness; Change in maximum carotid intima-media thickness
Secondary Outcomes: 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
Expected Total Enrollment:  835

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.

Ages Eligible for Study:  50 Years   -   70 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Netherlands, Gelderland
      Wageningen University, Wageningen,  Gelderland,  6700 EV,  Netherlands

Study chairs or principal investigators

Petra Verhoef, PhD,  Principal Investigator,  Wageningen Centre for Food Sciences   

Study ID Numbers:  Pou.0224L; ZonMw 20010002
Record last reviewed:  May 2005
Last Updated:  May 10, 2005
Record first received:  May 10, 2005
ClinicalTrials.gov Identifier:  NCT00110604
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-17