AtherosclerosisNCT00110604
The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
A study testing folic acid (0.8 mg) in people with Atherosclerosis and Vascular Disease, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Vascular Disease, Cognitive Decline
- What is being tested?
- folic acid (0.8 mg)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 835 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2000to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-70 years
- Men and post-menopausal women
- Women with a surgically removed uterus were required to be >=55 years
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis, Vascular Disease, Cognitive Decline, Hearing Loss, Inflammation, Age-Related Memory Disorder
- Being tested
- folic acid (0.8 mg)
- Keywords
- Folic acid, Atherosclerosis, Cognitive function, Hearing, Inflammation, Hemostasis, Arterial stiffness
- Medical subject headings
- Atherosclerosis, Vascular Diseases, Cognitive Dysfunction, Hearing Loss, Inflammation, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acid (0.8 mg)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean carotid intima-media thickness
Change in maximum carotid intima-media thickness
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2005 (estimated)
- Study startSep 2000
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 835 participants
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen Centre for Food Sciences, ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Petra Verhoef, PhD, Principal investigator, Wageningen Centre for Food Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110604
- Sponsor's protocol ID
- Pou.0224L
- Other IDs
- ZonMw 20010002
- Status last verified
- May 2005
- First submitted
- 10 May 2005
- Last updated
- 31 Dec 2008
- Results posted
- No
Publications
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.
PubMed 33564824Jung 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.
PubMed 21966393Schiepers 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.
PubMed 21791146Durga 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.
PubMed 21430116Durga 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.
PubMed 17240287Durga 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.
PubMed 17200216
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00110604
- Acronym / sponsor ID
- Pou.0224L
- Conditions
- Atherosclerosis, Vascular Disease, Cognitive Decline, Hearing Loss, Inflammation, Age-Related Memory Disorder
- Keywords
- Folic acid, Atherosclerosis, Cognitive function, Hearing, Inflammation, Hemostasis, Arterial stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 835 participants
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Wageningen Centre for Food Sciences, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Sep 2000
- Study completion
- Dec 2004
- First posted
- 11 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50-70 years
- Men and post-menopausal women
- Women with a surgically removed uterus were required to be >=55 years
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| folic acid (0.8 mg) | Behavioural | – |
Primary outcome
Change in mean carotid intima-media thickness
Change in maximum carotid intima-media thickness
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
- Derived from this study: PubMed 33564824van 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.
- Derived from this study: PubMed 21966393Jung 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.
- Derived from this study: PubMed 21791146Schiepers 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.
- Derived from this study: PubMed 21430116Durga 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.
- Derived from this study: PubMed 17240287Durga 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.
- Derived from this study: PubMed 17200216Durga 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.
- FACIT study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Verhoef, PhD principal investigator
Wageningen Centre for Food Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing folic acid (0.8 mg) in people with Atherosclerosis and Vascular Disease, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean carotid intima-media thickness. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110604, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2008.