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

This study has been completed.

Sponsor:

Collaborators:

Wageningen Centre for Food Sciences

ZonMw: The Netherlands Organisation for Health Research and Development

Information provided by:

Wageningen University

ClinicalTrials.gov Identifier:

NCT00110604

First received: May 10, 2005

Last updated: December 29, 2008

Last verified: May 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

May 10, 2005

Last Updated Date

December 29, 2008

Start Date ^ICMJE

September 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in mean carotid intima-media thickness
Change in maximum carotid intima-media thickness

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00110604 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

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

Intervention ^ICMJE

Behavioral: folic acid (0.8 mg)

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

835

Completion Date

December 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00110604

Other Study ID Numbers ^ICMJE

Pou.0224L, ZonMw 20010002

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wageningen University

Collaborators ^ICMJE

Wageningen Centre for Food Sciences
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators ^ICMJE

Principal Investigator:

Petra Verhoef, PhD

Wageningen Centre for Food Sciences

Information Provided By

Wageningen University

Verification Date

May 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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