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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33564325

Enrollment

819

Registered

2005-05-16

Start date

1999-09-01

Completion date

Unknown

Last updated

2022-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular disease Circulatory System Vascular disease

Interventions

Three-year long daily (oral) supplementation with 0.8 mg folic acid versus placebo pill.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Current use of vitamin supplements containing B vitamins 2. Hormone replacement therapy or lipid-lowering therapy

Design outcomes

Primary

Measure	Time frame
1. Change in mean carotid intima-media thickness 2. Change in maximum carotid intima-media thickness	—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026