Plain English Summary
Not provided at time of registration
Trial website
http://www.facit.net/facit_versie/explorer/groot/inhoud/algemeen.html
Contact information
Type
Scientific
Primary contact
Dr Jane Durga
ORCID ID
Contact details
Division of Human Nutrition
Wageningen University
Bode 62
P.O. Box 8129
Wageningen
6700 EV
Netherlands
+31 (0)31 748 5443
Jane.Durga@wur.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00110604
Protocol/serial number
NTR23
Study information
Scientific title
Acronym
FACIT
Study hypothesis
To determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, double blind, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Vascular disease
Intervention
Three-year long daily (oral) supplementation with 0.8 mg folic acid versus placebo pill.
Intervention type
Drug
Phase
Not Specified
Drug names
Folic acid
Primary outcome measure
1. Change in mean carotid intima-media thickness
2. Change in maximum carotid intima-media thickness
Secondary outcome measures
1. Change in carotid distension
2. Change in hearing levels (pure tone air conduction averages of 0.5, 1, and 2 kHz & 4, 6 and 8 kHz)
3. Cognitive performance at year three (cognitive domains: simple speed, cognitive flexibility, and memory; and information processing speed and semantic memory)
4. Inflammatory markers and haemostasis markers
Overall trial start date
01/09/1999
Overall trial end date
01/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 50 - 70 years old
2. Men and post-menopuasal women
3. Vitamin B12 greater than or equal to 200 pmol/l
4. Homocysteine greater than or equal to 13 umol/l
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
819
Participant exclusion criteria
1. Current use of vitamin supplements containing B vitamins
2. Hormone replacement therapy or lipid-lowering therapy
Recruitment start date
01/09/1999
Recruitment end date
01/12/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Division of Human Nutrition
Wageningen
6700 EV
Netherlands
Sponsor information
Organisation
Wageningen Centre for Food Sciences (WCFS) (The Netherlands)
Sponsor details
P.O. Box 557
Wageningen
6700 AN
Netherlands
+31 (0)31 748 5383
info@wcfs.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wageningen Centre for Food Sciences (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/17240287 (findings for the secondary endpoint - folic acid supplementation on cognitive performance)
2. http://www.ncbi.nlm.nih.gov/pubmed/17200216 (findings for the secondary endpoint - folic acid supplementation on hearing)
Publication citations
-
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, 369, 9557, 208-216, doi: 10.1016/S0140-6736(07)60109-3.
-
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, 146, 1, 1-9.