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| [ Print-friendly version ] |
| Supplementation with Folate (and vitamins B6 and B12) and/or Omega 3 Fatty Acids on the prevention of recurrent ischaemic events in patients who have already experienced a coronary or cerebrovascular event |
| ISRCTN | ISRCTN41926726 |
| DOI | 10.1186/ISRCTN41926726 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Supplementation with Folate (and vitamins B6 and B12) and/or Omega 3 Fatty Acids on the prevention of recurrent ischaemic events in patients who have already experienced a coronary or cerebrovascular event |
| Scientific title | |
| Acronym | SU.FOL.OM3 Study |
| Serial number at source | N/A |
| Study hypothesis |
Definitive proof that supplementation with B-vitamins or omega-3 fatty acids will lead to a reduced cardiovascular diseases morbidity and/or mortality is still scarce. The currently available intervention trials did either not have a study design that allows this conclusion or the results need to be reproduced before they can be regarded as definitive. (NB the trials with B vitamins evaluated mostly the effect on intermediate end-points).
Secondary intervention trials with hard endpoints and B-vitamin supplementation have recently started, but not all of these trials used a combination B vitamins and most trials used pharmacological doses. This has the disadvantage that the results will be difficult to translate into dietary advice. In addition, recent research has indicated that supplementation with 5-methyl tetrahydrofolate (5-methyl-THF), the most abundant natural folate vitamin, is safe and lowers homocysteine levels. This form of folate, in contrast to folic acid, does not lead to circulating unmetabolized folic acid. Unmetabolized folic acid is hypothesized to mask the hematological manifestations of a vitamin B12 deficiency, thereby predisposing subjects to irreversible neurological damage. Stable 5-methyl-THF was not available when other intervention studies started and therefore they all use folic acid. Taking all this information together, there is a need for a large double-blind placebo-controlled randomized intervention trial evaluating the effect of supplementation with B-vitamins (exchanging folic acid for 5-methyl-THF) and n-3 fatty acids in nutritional doses on hard cardiovascular endpoints. Therefore, we propose the following intervention study in which participants are SUpplemented with natural FOLate, vitamin B6 and B12 and/or OMega-3 fatty acids: the SU.FOL.OM3 study. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
1. Ethics Committee of Paris-Cochin (Comité Consultatif pour la Protection des Personnes se prêtant à la Recherche Biomédicale) (ref: CCPPRB n°1933)
2. National Committee of information and liberty (La Commission Nationale de l'Informatique et des Libertés [CNIL]) (ref: CNIL n° 901230) |
| Study design | Randomised controlled trial |
| Countries of recruitment | France |
| Disease/condition/study domain | Cardio and neurovascular diseases |
| Participants - inclusion criteria |
1. Participants should have experienced a coronary or cerebral event during 1 to 12 months before baseline. A coronary or cerebral event is defined as:
a. Myocardial infarction (validated and documented by a combination of clinical, enzymatic, or electrocardiogram [ECG] parameters) b. Acute coronary syndrome without necrosis (validated and documented by a combination of clinical, enzymatic or ECG parameters) c. A cerebral vascular ischemic accident (defined by criteria validated in epidemiological studies) 2. The participants should be 45-80 years at baseline |
| Participants - exclusion criteria |
1. Age <45 years or >80 years
2. Cardiovascular pathology not well defined 3. Patients that are incapable of understanding the study protocol 4. Patients with a pathology that might interfere with homocysteine or omega-3 fatty acid metabolism, in particular those that use methotrexate for the treatment of a cancer or rheumatoid arthritis and chronic renal failure (plasma level of creatinine >200 µmol/l or creatinine clearance <40 ml/min) 5. Patients with a non-cardiovascular pathology with a suspected survival time less than the 5 years period of the study (solid cancer, evolved dementia, leukemia etc.) |
| Anticipated start date | 15/04/2003 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 2,400 |
| Interventions | 5-methyl-THF (560 µg), vitamin B6 (3 mg) and B12 (20 µg) and/or omega-3 supplements (600 mg with an eicosapentaenoic acid [EPA]:docosahexaenoic acid [DHA] ratio of 2:1) versus placebo |
| Primary outcome measure(s) | Combination of myocardial infarction, cerebral vascular ischemic accident or cardiovascular deaths |
| Secondary outcome measure(s) |
1. Hospitalisation for coronary diseases
2. Hospitalisation for cardiac diseases 3. Hospitalisation for vascular diseases 4. Total mortality 5. Cardiovascular mortality 6. Myocardial infarctions 7. Acute coronary syndrome without necrosis 8. Ischemic cerebral vascular accidents 9. Arteriopathies 10. Venous thrombosis 11. Cancers |
| Sources of funding |
1. National Institute for Health and Medical Research (INSERM) (France)
2. French National Institute for Agricultural Research (INRA) 3. Ministry of the Higher Education and Research (France) 4. Pierre Fabre 5. Eprova 6. Danone Vitapole/Lu 7. Unilever Bestfoods France 8. Candia/ Yoplait |
| Trial website | |
| Publications |
1. 2003 publication on background and rationale of the SU.FOL.OM3 study in http://www.ncbi.nlm.nih.gov/pubmed/14625623
2. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18544171 3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21115589 4. 2012 cancer prevention results in http://www.ncbi.nlm.nih.gov/pubmed/22331983 4. 2012 blood pressure results in http://www.ncbi.nlm.nih.gov/pubmed/21801476 6. 2012 depressive symptoms results in http://www.ncbi.nlm.nih.gov/pubmed/22648722 |
| Contact name | Prof Serge Hercberg |
| Address |
U557 Inserm (UMR Inserm/Inra/Cnam)
5 rue Vertbois |
| City/town | Paris |
| Zip/Postcode | 75003 |
| Country | France |
| Sponsor | INSERM - Direction of Clinical Research (France) |
| Address | 101 rue de Tolbiac |
| City/town | Paris |
| Zip/Postcode | 75003 |
| Country | France |
| Sponsor website: | http://www.inserm.fr |
| Date applied | 14/09/2005 |
| Last edited | 10/09/2012 |
| Date ISRCTN assigned | 05/12/2005 |
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