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

NCT ID: NCT00110604

Last Updated: 2008-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

835 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2004-12-31

Brief Summary

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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

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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

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Atherosclerosis Vascular Disease Cognitive Decline Hearing Loss Inflammation Age-Related Memory Disorder

Keywords

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Folic acid Atherosclerosis Cognitive function Hearing Inflammation Hemostasis Arterial stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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folic acid (0.8 mg)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wageningen Centre for Food Sciences

OTHER

Sponsor Role collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Principal Investigators

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Petra Verhoef, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen Centre for Food Sciences

Locations

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Wageningen University

Wageningen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 33564824 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21966393 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21791146 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21430116 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17240287 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17200216 (View on PubMed)

Related Links

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http://www.theheart.org/article/765625.do

FACIT study website

Other Identifiers

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ZonMw 20010002

Identifier Type: -

Identifier Source: secondary_id

Pou.0224L

Identifier Type: -

Identifier Source: org_study_id