The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing - Full Text View

Sponsor:	Wageningen University
Collaborators:	Wageningen Centre for Food Sciences ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00110604

Purpose

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.

Condition	Intervention
Atherosclerosis Vascular Disease Cognitive Decline Hearing Loss Inflammation Age-Related Memory Disorder	Behavioral: folic acid (0.8 mg)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Atherosclerosis Hearing Disorders and Deafness Memory Vascular Diseases

Drug Information available for: Folic acid

U.S. FDA Resources

Further study details as provided by Wageningen University:

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

Estimated Enrollment:	835
Study Start Date:	September 2000
Estimated Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110604

Locations

Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV

Sponsors and Collaborators

Wageningen University

Wageningen Centre for Food Sciences

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Principal Investigator:

Petra Verhoef, PhD

Wageningen Centre for Food Sciences

More Information

Additional Information:

FACIT study website This link exits the ClinicalTrials.gov site

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Sep 23.

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(1-4). Am J Clin Nutr. 2011 May;93(5):941-9. Epub 2011 Mar 23.

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.

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. Summary for patients in: Ann Intern Med. 2007 Jan 2;146(1):I20.

ClinicalTrials.gov Identifier:	NCT00110604 History of Changes
Other Study ID Numbers:	Pou.0224L, ZonMw 20010002
Study First Received:	May 10, 2005
Last Updated:	December 29, 2008
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:

Folic acid
Atherosclerosis
Cognitive function
Hearing

Inflammation
Hemostasis
Arterial stiffness

Additional relevant MeSH terms:

Atherosclerosis
Hearing Loss
Deafness
Inflammation
Memory Disorders
Vascular Diseases
Cognition Disorders
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Neurobehavioral Manifestations
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Folic Acid
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012