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 (NCT) | NCT00110604 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NTR23 |
| Sponsor | Wageningen Centre for Food Sciences (WCFS) (The Netherlands) |
| Funders | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands), Wageningen Centre for Food Sciences (The Netherlands) |
- Submission date
- 16/05/2005
- Registration date
- 16/05/2005
- Last edited
- 23/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jane Durga
Scientific
Scientific
Division of Human Nutrition
Wageningen University
Bode 62
P.O. Box 8129
Wageningen
6700 EV
Netherlands
| Phone | +31 (0)31 748 5443 |
|---|---|
| Jane.Durga@wur.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Folic acid |
| Primary outcome measure(s) |
1. Change in mean carotid intima-media thickness |
| Key secondary outcome measure(s) |
1. Change in carotid distension |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Division of Human Nutrition
Wageningen
6700 EV
Netherlands
6700 EV
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| 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 |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/05/2022: Publication references added.
