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

NCT00110604 | Completed

• 2 other identifiers: Pou.0224LZonMw 20010002
• Study Type: interventional
• Target: 835
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Folic acid; Atherosclerosis; Cognitive function; Hearing; Inflammation; Hemostasis; Arterial stiffness

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

folic acid (0.8 mg) BEHAVIORAL

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Men and post-menopausal women
• Women with a surgically removed uterus were required to be \>=55 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Wageningen Centre for Food Sciences: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6700 EV, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 33564824 DERIVED

• 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.

  PMID: 21966393 DERIVED

• 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.

  PMID: 21791146 DERIVED

• 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.

  PMID: 21430116 DERIVED

• 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.

  PMID: 17240287 DERIVED

• 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.

  PMID: 17200216 DERIVED

Related Links

• FACIT study website

MeSH Terms

Conditions

Atherosclerosis; Vascular Diseases; Cognitive Dysfunction; Hearing Loss; Inflammation; Memory Disorders

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Petra Verhoef, PhD

  Wageningen Centre for Food Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2005
• First Posted: May 11, 2005
• Study Start: September 1, 2000
• Study Completion: December 1, 2004
• Last Updated: December 31, 2008

Record last verified: 2005-05

Locations

NL (1)