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


- candidate number0
- NTR NumberNTR23
- ISRCTNISRCTN33564325
- Date ISRCTN created16-mei-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR21-jan-2005
- Secondary IDsZonMW 2001002  
- Public TitleFolic acid and carotid intima-media thickness: a 3-year RCT examining the effects of folic acid supplementation on vascular disease.
- Scientific TitleFolic acid and carotid intima-media thickness: a 3-year RCT examining the effects of folic acid supplementation on vascular disease.
- ACRONYMFACIT
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedVascular disease
- Inclusion criteria1. 50-70 years old;
2. Men and post-menopuasal women;
3. Vitamin B12 >=200 pmol/L;
4. Homocysteine >=13 umol/L.
- Exclusion criteria1. No current use of vitamin supplements containing B vitamins;
2. No hormone replacement therapy or lipid-lowering therapy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-1999
- planned closingdate1-dec-2004
- Target number of participants819
- Interventions3-year long daily (oral) supplementation with 0.8 mg folic acid vs. placebo pill.
- Primary outcomeProgression 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.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. Jane Durga
- CONTACT for SCIENTIFIC QUERIESDr. Jane Durga
- Sponsor/Initiator Wageningen Center for Food Sciences (WCFS)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Wageningen Center for Food Sciences
- Publications1. 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.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD5-jul-2005 - 23-jun-2008


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