Status:
COMPLETED
The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Wageningen Centre for Food Sciences
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Atherosclerosis
Vascular Disease
Eligibility:
All Genders
50-70 years
Phase:
NA
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 diseas...
Eligibility Criteria
Inclusion
- 50-70 years
- Men and post-menopausal women
- Women with a surgically removed uterus were required to be \>=55 years
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
835 Patients enrolled
Trial Details
Trial ID
NCT00110604
Start Date
September 1 2000
End Date
December 1 2004
Last Update
December 31 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV