Folic Acid and Carotid Intima-media Thickness: a 3-year randomised controlled trial (RCT) examining the effects of folic acid supplementation on vascular disease

ISRCTN	ISRCTN33564325
DOI	https://doi.org/10.1186/ISRCTN33564325
ClinicalTrials.gov number	NCT00110604
Secondary identifying numbers	NTR23

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jane Durga
Scientific

Division of Human Nutrition
Wageningen University
Bode 62
P.O. Box 8129
Wageningen
6700 EV
Netherlands

Phone	+31 (0)31 748 5443
Email	Jane.Durga@wur.nl

Study design	Randomised, double blind, placebo controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Folic Acid and Carotid Intima-media Thickness: a 3-year randomised controlled trial (RCT) examining the effects of folic acid supplementation on vascular disease
Study acronym	FACIT
Study objectives	To determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Vascular disease
Intervention	Three-year long daily (oral) supplementation with 0.8 mg folic acid versus placebo pill.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/09/1999
Completion date	01/12/2004

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	819
Key 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
Key exclusion criteria	1. Current use of vitamin supplements containing B vitamins 2. Hormone replacement therapy or lipid-lowering therapy
Date of first enrolment	01/09/1999
Date of final enrolment	01/12/2004

Division of Human Nutrition

Wageningen
6700 EV
Netherlands

Wageningen Centre for Food Sciences (WCFS) (The Netherlands)
Research organisation

P.O. Box 557
Wageningen
6700 AN
Netherlands

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Wageningen Centre for Food Sciences (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		02/01/2007		Yes	No
Results article		20/01/2007		Yes	No
Results article		01/05/2011	23/05/2022	Yes	No
Results article		01/06/2011	23/05/2022	Yes	No
Results article	post hoc analysis	06/04/2021	23/05/2022	Yes	No

23/05/2022: Publication references added.