Back to resultsThe Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
Primary Purpose
Atherosclerosis, Vascular Disease, Cognitive Decline
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
folic acid (0.8 mg)
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis focused on measuring Folic acid, Atherosclerosis, Cognitive function, Hearing, Inflammation, Hemostasis, Arterial stiffness
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
Sites / Locations
- Wageningen University
Outcomes
Primary Outcome Measures
Change in mean carotid intima-media thickness
Change in maximum carotid intima-media thickness
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00110604
First Posted
May 10, 2005
Last Updated
December 29, 2008
Sponsor
Wageningen University
Collaborators
Wageningen Centre for Food Sciences, ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00110604
Brief Title
The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
Official Title
The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wageningen University
Collaborators
Wageningen Centre for Food Sciences, ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Vascular Disease, Cognitive Decline, Hearing Loss, Inflammation, Age-Related Memory Disorder
Keywords
Folic acid, Atherosclerosis, Cognitive function, Hearing, Inflammation, Hemostasis, Arterial stiffness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
835 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
folic acid (0.8 mg)
Primary Outcome Measure Information:
Title
Change in mean carotid intima-media thickness
Title
Change in maximum carotid intima-media thickness
Secondary Outcome Measure Information:
Title
Change in carotid distension
Title
Change in hearing levels (pure tone air conduction averages of 0.5, 1, and 2 kHz & 4, 6 and 8 kHz)
Title
Cognitive performance at year 3 (cognitive domains: simple speed, cognitive flexibility, and memory; and information processing speed and semantic memory)
Title
Inflammatory markers and hemostasis markers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Verhoef, PhD
Organizational Affiliation
Wageningen Centre for Food Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wageningen University
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6700 EV
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
33564824
Citation
van Soest APM, van de Rest O, Witkamp RF, de Groot LCPGM. Positive effects of folic acid supplementation on cognitive aging are dependent on omega-3 fatty acid status: a post hoc analysis of the FACIT trial. Am J Clin Nutr. 2021 Apr 6;113(4):801-809. doi: 10.1093/ajcn/nqaa373.
Results Reference
derived
PubMed Identifier
21966393
Citation
Jung AY, Smulders Y, Verhoef P, Kok FJ, Blom H, Kok RM, Kampman E, Durga J. No effect of folic acid supplementation on global DNA methylation in men and women with moderately elevated homocysteine. PLoS One. 2011;6(9):e24976. doi: 10.1371/journal.pone.0024976. Epub 2011 Sep 23.
Results Reference
derived
PubMed Identifier
21791146
Citation
Schiepers OJ, van Boxtel MP, de Groot RH, Jolles J, Kok FJ, Verhoef P, Durga J. DNA methylation and cognitive functioning in healthy older adults. Br J Nutr. 2012 Mar;107(5):744-8. doi: 10.1017/S0007114511003576. Epub 2011 Jul 27.
Results Reference
derived
PubMed Identifier
21430116
Citation
Durga J, Bots ML, Schouten EG, Grobbee DE, Kok FJ, Verhoef P. Effect of 3 y of folic acid supplementation on the progression of carotid intima-media thickness and carotid arterial stiffness in older adults. Am J Clin Nutr. 2011 May;93(5):941-9. doi: 10.3945/ajcn.110.006429. Epub 2011 Mar 23.
Results Reference
derived
PubMed Identifier
17240287
Citation
Durga J, van Boxtel MP, Schouten EG, Kok FJ, Jolles J, Katan MB, Verhoef P. Effect of 3-year folic acid supplementation on cognitive function in older adults in the FACIT trial: a randomised, double blind, controlled trial. Lancet. 2007 Jan 20;369(9557):208-16. doi: 10.1016/S0140-6736(07)60109-3.
Results Reference
derived
PubMed Identifier
17200216
Citation
Durga J, Verhoef P, Anteunis LJ, Schouten E, Kok FJ. Effects of folic acid supplementation on hearing in older adults: a randomized, controlled trial. Ann Intern Med. 2007 Jan 2;146(1):1-9. doi: 10.7326/0003-4819-146-1-200701020-00003.
Results Reference
derived
Links:
URL
http://www.theheart.org/article/765625.do
Description
FACIT study website
Learn more about this trial
The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
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