Condition category
Circulatory System
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
02/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.wcfs.nl

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes