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| Plasma homocysteine response to folic acid intervention |
| Source of record | UK Trials |
| ISRCTN | ISRCTN45296887 |
| Date ISRCTN assigned | 05/03/2008 |
| Local reference number(s) | N/A |
| Public title | Plasma homocysteine response to folic acid intervention |
| Scientific title | A dose finding trial in ischaemic heart disease patients and healthy controls to determine whether chronic exposure to low-dose folic acid can lower homocysteine |
| Acronym | N/A |
| Disease/condition/study domain | Ischaemic heart disease |
| Study hypothesis | Low dose folic acid (0.2 mg/d) administered chronically will significantly lower plasma homocysteine in ischaemic heart disease (IHD) patients and healthy age-sex matched controls. Previous studies may have overestimated the folic acid dose required to lower homocysteine because of too-short an intervention period to observe the full extent of the response to low folic acid doses and concluded that much higher doses were required for maximal homocysteine-lowering. If the hypothesis is confirmed the findings will have important implications for governments worldwide currently considering food fortification with folic acid, which although primarily aimed at reducing neural tube defects (NTDs), is expected to have important benefits in terms of the primary and secondary prevention of cardiovascular disease (CVD) via a homocysteine-lowering effect. |
| Design/methodology | Double-blinded, randomised, placebo controlled dose finding trial with folic acid |
| Research ethics review | The study was approved by the University of Ulster Ethics committee in March 2000 (ref: 01/17). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male and female, any age 2. IHD Patients: 2.1. Proven myocardial infarction more than three months previously 2.2. IHD on coronary angiography 2.3. A clinical diagnosis of angina confirmed by electrocardiogram (ECG) 3. Control subjects: healthy subjects age- and sex-matched with the IHD group from the local community |
| Participants - exclusion criteria | 1. IHD patients: 1.1. History of diabetes 1.2. Hepatic or renal disease 1.3. Haematological disorders 1.4. Use of B-vitamin supplements or use of medication known to interfere with folate metabolism 2. Healthy controls in addition had no history of CVD |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 31/03/2001 |
| Anticipated end date | 31/12/2004 |
| Status of trial | Completed |
| Target number of participants | n = 200 (100 patients, 100 controls) |
| Interventions | In both IHD and healthy control groups, participants were stratified into tertiles of homocysteine concentration (from the screening blood sample). Subjects in each stratum were then randomised to receive placebo, 0.2, 0.4 or 0.8 mg/d folic acid for a total intervention period of 26 weeks. To maximise compliance, vitamins were distributed every three weeks to the participants¿ homes in seven-day pillboxes. The pillboxes were then collected and any unused pills recorded in order to monitor compliance. Total intervention period of 26 weeks for all treatment arms. |
| Primary outcome measure(s) | Plasma homocysteine, measured at baseline, 6 weeks and 12 weeks in a subset, and at 26 weeks. |
| Secondary outcome measure(s) | 1. Serum folate, measured at baseline and at 26 weeks 2. Erythrocyte glutathione reductase activity coefficient (EGRac): an indicator of riboflavin status), measured at baseline 2. Plasma pyridoxal phosphate: an indicator of vitamin B6 status, measured at baseline 3. Serum vitamin B12, measured at baseline |
| Sources of funding | Northern Ireland Chest Heart and Stroke Association (UK) |
| Sponsor name | University of Ulster (UK) |
| Sponsor details | c/o Mary Ward School of Biomedical Sciences Cromore Road Coleraine United Kingdom BT52 1SA |
| Sponsor telephone | +44 (0)28 7032 3076 |
| Sponsor email | mw.ward@ulster.ac.uk |
| Sponsor website | http://www.ulster.ac.uk/ |
| Contact name | Dr Mary Ward |
| Contact details | Northern Ireland Centre for Food and Health School of Biomedical Sciences University of Ulster Coleraine United Kingdom BT521SA |
| Contact telephone | +44 (0)28 7032 3076 |
| Contact email | mw.ward@ulster.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN45296887 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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