Folic acid and carotid intima-media thickness: a 3-year RCT examining the effects of folic acid supplementation on vascular disease.

No registrations found.

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Ethical review

Positive opinion

Status

Recruitment stopped

Health condition type

Study type

Interventional

ID

NL-OMON21998

NTR

Brief title

FACIT

Intervention

Outcome measures

Progression in intima-media thickening of the common carotid artery, progression in carotid arterial stiffening, decline in cognitive performance using a battery of test, decline in hearing threshold levels.

N/A

Background summary

N/A

Study objective

N/A

Study design

N/A

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

Public

Wageningen University, Division of Human Nutrition,
P.O. Box 8129
Jane Durga
Wageningen 6700 EV
The Netherlands
+31 (0)317 485443
Jane.Durga@wur.nl

Scientific

Wageningen University, Division of Human Nutrition,
P.O. Box 8129
Jane Durga
Wageningen 6700 EV
The Netherlands
+31 (0)317 485443
Jane.Durga@wur.nl

Inclusion criteria

1. 50-70 years old;

2. Men and post-menopuasal women;

3. Vitamin B12 >=200 pmol/L;

4. Homocysteine >=13 umol/L.

Exclusion criteria

1. No current use of vitamin supplements containing B vitamins;

2. No hormone replacement therapy or lipid-lowering therapy.

Design

Study type :

Interventional

Intervention model :

Parallel

Allocation :

Randomized controlled trial

Masking :

Double blinded (masking used)

Control :

Placebo

Recruitment

Recruitment status :

Recruitment stopped

Start date (anticipated) :

01-09-1999

Enrollment :

819

Type :

Actual

Positive opinion

Date :

21-01-2005

Application type :

First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register	ID
NTR-new	NL2
NTR-old	NTR23
Other	: ZonMW 2001002
ISRCTN	ISRCTN33564325

Summary results

1. Atherosclerosis. 2005 Apr;179(2):285-92. Epub 2004 Dec 15; 
 
2. Neurobiol Aging. 2006 Feb;27(2):334-43. Epub 2005 Feb 24; 
 
3. Lancet. 2007 Jan 20;369(9557):208-16; 
 
4. J Nutr Health Aging. 2007 Jul-Aug;11(4):320-4; 
 
5. Lancet. 2007 Jul 21;370(9583):216; 
 
6. Am J Clin Nutr. 2007 Nov;86(5):1479-85.

Folic acid and carotid intima-media thickness: a 3-year RCT examining the effects of folic acid supplementation on vascular disease.

ID

Source

Brief title

Intervention

Outcome measures

Primary outcome

Secondary outcome

Background summary

Study objective

Study design

Intervention

Inclusion criteria

Exclusion criteria

Design

Recruitment

Followed up by the following (possibly more current) registration

Other (possibly less up-to-date) registrations in this register

In other registers

Summary results

Folic acid and carotid intima-media thickness: a 3-year RCT examining the effects of folic acid supplementation on vascular disease.

Summary

ID

Source

Brief title

Intervention i

Outcome measures

Primary outcome

Secondary outcome

Study description

Background summary

Study objective

Study design

Intervention

Contacts

Eligibility criteria

Inclusion criteria

Exclusion criteria

Study design

Design

Recruitment

Ethics review

Study registrations

Followed up by the following (possibly more current) registration

Other (possibly less up-to-date) registrations in this register

In other registers

Study results

Summary results

Intervention